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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-005275-16
    Sponsor's Protocol Code Number:IEOS672/611
    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:2012-06-12
    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 number2011-005275-16
    A.3Full title of the trial
    Radio-guided minimally invasive resection of early colon cancer
    Resezione chirurgica mini invasiva radio-guidata dei tumori del colon in stadio iniziale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Validation of a scintigraphic method for localyzing small colonic lesions prior to minimally invasive resection
    Validazione di una metodica scintigrafica per la localizzazione di piccole lesioni tumorali del colon prima di un intervento di chirurgia mini invasiva
    A.4.1Sponsor's protocol code numberIEOS672/611
    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 SponsorISTITUTO EUROPEO DI ONCOLOGIA
    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 supportIstituto Europeo Oncologia
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportFondazione Umberto Veronesi
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo Oncologia
    B.5.2Functional name of contact pointUfficio studi clinici
    B.5.3 Address:
    B.5.3.1Street Addressvia Ramusio 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number02 57 48 98 48
    B.5.5Fax number02 57 48 97 81
    B.5.6E-mailufficio.studiclinici@ieo.it
    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.2.1.1.1Trade name MAASOL
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare SRL
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN ALBUMIN AS MACROAGGREGATES
    D.3.9.4EV Substance CodeSUB23304
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Yes
    D.3.11.13.1Other medicinal product typeradiofarmaco
    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.2.1.1.1Trade name NANOCOLL
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare SRL
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN ALBUMIN PURIFIED
    D.3.9.4EV Substance CodeSUB20885
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Yes
    D.3.11.13.1Other medicinal product typeradiofarmaco
    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
    colon cancer
    tumore del colon
    E.1.1.1Medical condition in easily understood language
    early colon cancer
    tumore del colon in fase iniziale
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10009944
    E.1.2Term Colon 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 main objective of this study is the evaluation of the feasibility and efficacy of ROLL to localize early colon cancers or scars of endoscopic polypectomies before minimally-invasive colon resections.
    L’obiettivo principale di questo studio è la valutazione della fattibilità e della efficacia della tecnica ROLL al fine di localizzare tumori precoci del colon o cicatrici da polipectomie endoscopiche antecedenti alla resezione al colon mini invasiva.
    E.2.2Secondary objectives of the trial
    Secondary objective is validation of ROLL technique to identify sentinel lymphnodes.
    Obiettivo secondario è la validazione della tecnica ROLL ai fini della identificazione dei linfonodi sentinella.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged ≥ 18 years - Able to provide written informed consent - Diagnosis of early (T1) colon cancer or of endoscopically removed colonic polyp, with malignant histology (infiltration of the submucosa) and requiring surgical radicalization - Colon cancer suitable for resection by minimally invasive surgery - Patient fit for robotic-assisted or standard laparoscopic colon resection - American Society of Anesthesiologists (ASA) physical status ≤3
    età ≥ 18 anni - Consenso Informato datato e firmato -diagnosi precoce di carcinoma del colon (T1) o di polipo del colon rimosso endoscopicamente con istologico di tumore maligno (infiltrazione della sottomucosa) e che richiede un intervento radicale - Tumore del colon che sia resecabile tramite chirurgia mini-invasiva - paziente che sia favorevole a una chirurgia laparoscopica standard o assistita da robot - ASA ≤ 3
    E.4Principal exclusion criteria
    Benign lesions of the colon or of the rectum above 12 cm from the anal verge - Benign or malignant diseases of the anal canal - Synchronous colorectal tumours requiring multi-segment surgical resection - Co-existent inflammatory bowel disease - Clinical or radiological evidence of metastatic spread - Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable) - History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements - Pregnancy - Breast feeding - Participation in another colon cancer clinical trial relating to lesion mapping techniques
    - lesioni benigne del colon o del retto oltre i 12 cm dal margine anale - patologie benigne o maligne del canale anale - tumori colon rettali sincroni che richiedono una resezione chirurgica multi-segmentaria - contemporanea patologia infiammatoria intestinale - evidenza clinica o radiologica di diffusione metastatica - diagnosi concomitante o precedente di tumore invasivo entro i 5 anni che potrebbe confondere la diagnosi (sono accettati i tumori della pelle o superficiali trattati con intento curativo) - Storia di disturbi psichiatrici o di dipendenza o di altre condizioni cliniche che, a giudizio dello sperimentatore, precluderebbero il paziente dal soddisfare i requisiti dello studio - gravidanza - allattamento - partecipazione in altro studio clinico riguardante la tecnica di mappatura delle lesioni del colon
    E.5 End points
    E.5.1Primary end point(s)
    occurrence of positive radioguided identification of the primary tumour site or of the scar of endoscopic polypectomy
    identificazione del tumore primitivo o della cicatrice della polipectomia endosopica
    E.5.1.1Timepoint(s) of evaluation of this end point
    the evaluation is performed at the time of surgery and after the histopathologic examination.
    la valutazione avviene al momento dell'intervento chirurgico e dopo la verifica dell'esame istopatologico
    E.5.2Secondary end point(s)
    identification of sentinel lymphonodes
    identificazione dei linfonodi sentinella
    E.5.2.1Timepoint(s) of evaluation of this end point
    after the histopathologic examination
    dopo l'esame istopatologico
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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 No
    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 years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-06-12. Yes
    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 state34
    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)
    routine assistance program
    normale programma di assistenza
    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 Decision2012-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
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