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    Summary
    EudraCT Number:2019-002074-32
    Sponsor's Protocol Code Number:IFOM-CPT005/2019/PO004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002074-32
    A.3Full title of the trial
    POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS
    TRATTAMENTO POST-CHIRURGICO DI PAZIENTI AFFETTI DA TUMORI DEL COLON DI STADIO III E II-ALTO RISCHIO GUIDATO DALLA BIOPSIA LIQUIDA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF COLON CANCER PATIENTS
    TRATTAMENTO POST-CHIRURGICO DI PAZIENTI AFFETTI DA TUMORI DEL COLON GUIDATO DALLA BIOPSIA LIQUIDA.
    A.3.2Name or abbreviated title of the trial where available
    PEGASUS trial
    studio PEGASUS
    A.4.1Sponsor's protocol code numberIFOM-CPT005/2019/PO004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIFOM - Istituto FIRC di Oncologia Molecolare - Milano
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIFOM - Istituto FIRC di Oncologia Molecolare - Milano
    B.5.2Functional name of contact pointPrecision Oncology Unit
    B.5.3 Address:
    B.5.3.1Street AddressVia Adamello 16
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20139
    B.5.3.4CountryItaly
    B.5.4Telephone number02574303862
    B.5.6E-mailsilvia.marsoni@ifom.eu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIrinotecan
    D.3.2Product code [IRI]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRINOTECAN CLORIDRATO TRIIDRATO
    D.3.9.1CAS number 136572-09-3
    D.3.9.2Current sponsor codeIrinotecan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameoxaliplatinum
    D.3.2Product code [oxaliplatinum]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXALIPLATINO
    D.3.9.1CAS number 63121-00-6
    D.3.9.2Current sponsor codeOXA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecapecitabine
    D.3.2Product code [capecitabine]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPECITABINA
    D.3.9.1CAS number 154361-50-9
    D.3.9.2Current sponsor codeCAPECITIABINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name5-FU
    D.3.2Product code [5-FU]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUOROURACILE
    D.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor code5-FU
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stage III and high-risk stage II colon cancer
    Tumori del colon di stadio III e II alto rischio
    E.1.1.1Medical condition in easily understood language
    Colon cancer
    Tumori del colon
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to study the feasibility of using liquid biopsy to guide the post-surgical and post-adjuvant clinical management of stage III and high-risk stage II (T4N0) MSS colon cancer patients.
    Feasibility is defined as the ability of at least two subsequent negative ctDNA determination to identify patients that will be NED (without radiologic evidence of metastasis) 2 years aftersurgery
    L’obiettivo primario dello studio è di studiare la fattibilità di usare la biopsia liquida per guidare la gestione clinica post-chirurgica e post-adiuvante dei pazienti affetti da tumori MSS del colon di stadio III e II ad alto rischio (T4N0).
    La fattibilità è definita come la capacità di almeno 2 biopsie liquide consecutive negative di identificare i pazienti che a 2 anni dalla chirurgia non hanno evidenza radiologica di remissione metastatica.
    E.2.2Secondary objectives of the trial
    - To compare the DFS and OS rates at 2,3 and 5 years in a cohort of 140 stage III and high-risk stage II (only T4N0) MSS colon cancer patients treated post-surgically with a LB guided strategy, with the DFS and OS rates of a 1:3 phenotypically matched cohort of the TOSCA trial treated with FOLFOX/CAPOX either at 3 or 6 months.
    • To compare the safety profile in a cohort of 140 stage III and high-risk stage II (only T4N0) MSS colon cancer patients treated with a liquid biopsy-guided strategy, with the safety profile of 1:3 phenotypically matched cohort of the TOSCA trial treated with FOLFOX/CAPOX at 3 or 6 months.
    • To validate LB seroconversion as a proxy of therapy efficacy and to compare its performance with CEA testing
    whenever CEA levels are above the normal values.
    • To study the QoL of patients in a cohort of 140 stage III and high-risk stage II (only T4N0) MSS colon cancer patients treated post-surgically with a liquid biopsy-guided strategy
    Confrontare le % DFS e OS a 2,3,5 anni in una coorte di 140 pazienti con cancro MSS del colon stadio III e II ad alto rischio trattati postchirurgicamente con strategia terapeutica guidata da LB, con le % di DFS e OS di una coorte storica accoppiata in rapporto 1:3 dallo studio clinico TOSCA trattati con FOLFOX/CAPOX per 3 o 6 mesi.
    Confrontare il profilo di sicurezza in una coorte di 140 pazienti con cancro MSS del colon di stadio III e II ad alto rischio trattati postchirurgicamente con strategia terapeutica guidata da LB, con quello di una coorte storica accoppiata in rapporto 1:3 dallo studio clinico TOSCA trattati con FOLFOX/CAPOX per 3 o 6 mesi.
    Validare la sieroconversione della LB come surrogato dell’efficacia della terapia e confrontarla con la misurazione del CEA quando è sopra i livelli normali.
    Studiare la QoL in una coorte di 140 pazienti con cancro del colon MSS di stadio III e II ad alto rischio trattati postchirurgicamente con una strategia terapeutica guidata da LB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pegasus trial written informed consent.
    2. Age = 18 years.
    3. Histologically confirmed diagnosis of operable stage III or T4N0 stage II colon cancer located 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.
    4. Availability of plasma collected prior to surgery.
    5. Availability of the original FFPE tumor tissue.
    6. Acceptance to undergo at least all the interventional liquid biopsies.
    7. ECOG performance status 0-1.
    8. Normal organ functions. (as defined in section 9.3)
    9. Women with childbearing potential should complete a pregnancy test and be willing to use highly effective contraceptive methods.
    1. Consenso informato scritto dello studio Pegasus.
    2. Età = 18 anni.
    3. Diagnosi istologica di tumore operabile del colon di stadio III e II (T4N0), localizzato a 12 cm dal margine anale all’endoscopia e sopra la
    piega peritoneale alla chirurgia.
    4. Disponibilità di un prelievo di plasma pre-chirurgico.
    5. Disponibilità del blocchetto di tessuto tumorale FFPE.
    6. Accettazione di eseguire almeno tutte le biopsie liquide interventistiche.
    7. Stato della condizione secondo ECOG 0-1.
    8. Funzioni d’organo normali (come definito nella sezione 9.3).
    9. Donne in età fertile dovranno eseguire un test di gravidanza e dovranno accettare di utilizzare metodi contracettivi altamente efficaci
    E.4Principal exclusion criteria
    1. Patients having a MSI-H/MMRd tumor are excluded from the study (done according to standard clinical practice).
    2. History of another neoplastic disease, unless in remission for = 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
    3. Had an incomplete diagnostic colonoscopy and/or polyps removal.
    4. Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).
    5. Current or recent treatment with another investigational drug or participation in another investigational study
    6. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
    7. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
    8. Inadequate contraception (male or female patients) if of childbearing or procreational potential.
    9. Clinically relevant cardiovascular disease.
    10. Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
    11. Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
    12. Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
    13. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
    14. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive)or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C isrequired unless mandated by local health authority.
    15. Has a known history of active TB (Bacillus Tuberculosis).
    1. I pazienti con tumori MSI-H/MMRd sono esclusi dallo studio (il test viene eseguito secondo pratica clinica)
    2. Storia di un’altra malattia neoplastica, a meno che in remissione da = 5 anni. I Pazienti con carcinoma basale della pelle, carcinoma squamoso della pelle, o carcinoma in situ (as es. al seno o alla cervice) che sono andati incontro a terapia con intento curativo non sono esclusi.
    3. Hanno effettuato una colonscopia diagnostica non completa e/o con rimozione incompleta dei polipi.
    4. Evidenza macroscopica o microscopica di tumore residuo (reseazione R1 o R2). I pazienti non devono mai avere avuto nessuna evidenza di malattia metastatica (inclusa la presenza di cellule tumorali nel lavaggio
    peritoneale).
    5. Trattamento in corso o recente con un altro farmaco sperimentale o partecipazione in un altro studio clinico.
    6. Pazienti incapace di attenersi al protocollo di studio a causa di ragioni psicologiche, sociali o geografiche.
    7. È una donna gravida o in allattamento, o in programma di concepire (sia uomo che donna) durante la durata dello studio.
    8. Pazienti (uomo e donna) che eseguono contraccezione inadeguata se fertili.
    9. Malattie cardiovascolari clinicamente rilevanti.
    10. Occlusione intestinale acuta o subacute, o storia di malattia cronica infiamamtoria intestinale.
    11. Neuropatia pre-esistente di grado >1. Allergia di grado 3 o 4 a qualsiasi componente dei trattamenti.
    12. Ha la sindrome di Gilbert o variante germinale UGT1A1 *28/*28 in omozigosi.
    13. Storia nota di infezione da HIV. Nota: il test per HIV non è richiesto.
    14. Storia nota di infezione da Epatite B (definita come reattività all’antigene di superfice [HBsAg]) o infezione nota in corso da EpatiteC. Nota: nessun test per Epatite B e C è necessario a meno che richiesto dalle autorità sanitarie locali
    15. Storia nota di infezione attiva di Tubercolosi (Bacillus Tuberculosis).
    E.5 End points
    E.5.1Primary end point(s)
    Number of post-surgery and post-adjuvant false negative cases after a double ctDNA-negative detection, defined as cases that become positive at subsequent interventional LB or that experience radiological relapse within 2 years.
    Numero di casi falsi negativi post-chirugici e post-adiuvanti dopo una doppia biopsia liquida negativa, definiti come casi che diventano positivi ad una successiva biopsia liquida o che vanno incontro a remissione radiologica entro
    i 2 anni dalla chirurgia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 2 years from surgery
    2 anni dalla chirurgia
    E.5.2Secondary end point(s)
    Safety and tolerability avvording to CTCAE version 4.03; Disease-Free Survival (DFS) at 2 and 3-years, Overall Survival (OS) at 5-years.; Number of patients experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any chemotherapy regimen remaining disease free at 2 and 3 years.; Assessment of QLQ-C30 and CR-29 EORTC questionnaires
    Sicurezza e tollerabilità secondo la versione 4.03 del CTCAE; Sopravvivenza libera da malattia (DFS) a 2 e 3 anni, Sopravvivenza (OS) a 5 anni; Numero di pazienti in cui si ha sieroconversione (ovvero LB positiva che diventa negativa) dopo qualsiasi chemioterapia e che rimangono liberi da malattia a 2 e 3 anni.; Compilazione ed analisi dei questionari EORTC QLQ-C30 e CR-29
    E.5.2.1Timepoint(s) of evaluation of this end point
    the whole study; 2, 3 and 5 years; at 2 and 3 years; the whole study
    durante tutto lo studio; 2, 3 e 5 anni; 2 e 3 anni; durante tutto lo studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Feasibility of using liquid biopsy to guide post-surgical and post-adjuvant clinical management of patients with colon cancer
    Feasibility of using liquid biopsy to guide post-surgical and post-adjuvant clinical management of patients with colon cancer
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    coorte storica di studio clinico TOSCA
    historical cohort of the TOSCA clinical trial
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    clinical standard therapies
    terapie da pratica clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-17
    P. End of Trial
    P.End of Trial StatusOngoing
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