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    Summary
    EudraCT Number:2022-002536-32
    Sponsor's Protocol Code Number:GREEN-EX
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-02-06
    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 number2022-002536-32
    A.3Full title of the trial
    Indocyanine green to assess vascularity of ileal conduit anastomosis and regulate ureteral resection margins during pelvic exenteration for recurrent/persistent gynecological cancer. A pilot study
    Verde di indocianina per valutare la vascolarizzazione dell'anastomosi uretero-ileale, e regolare i margini di resezione ureterale durante l'eviscerazione pelvica per recidiva o persistenza di tumori ginecologici. Studio pilota
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Indocyanine green to assess vascularity of ileal conduit anastomosis and regulate ureteral resection margins during pelvic exenteration for recurrent/persistent gynecological cancer. A pilot study
    Verde di indocianina per valutare la vascolarizzazione dell'anastomosi uretero-ileale, e regolare i margini di resezione ureterale durante l'eviscerazione pelvica per recidiva o persistenza di tumori ginecologici. Studio pilota
    A.3.2Name or abbreviated title of the trial where available
    GREEN-EX
    GREEN-EX
    A.4.1Sponsor's protocol code numberGREEN-EX
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Policlinico Universitario A. Gemelli IRCCS
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressL.go A Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.6E-maildirezione.scientifica@policlinicogemelli.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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameVerdye
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNverde indocianina
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Patients with gynecological cancers undergoing pelvic exenteration
    pazienti con tumori ginecologici che saranno sottoposte a chirurgia per eviscerazione pelvica
    E.1.1.1Medical condition in easily understood language
    Patients with gynecological cancers undergoing pelvic exenteration
    pazienti con tumori ginecologici che saranno sottoposte a chirurgia per eviscerazione pelvica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10014758
    E.1.2Term Endometrial neoplasia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10008354
    E.1.2Term Cervix neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047777
    E.1.2Term Vulvar 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 endpoint of the study is to assess the incidence of benign ureteric strictures in patients undergoing ICG perfusion-modulated resection of ureters undergoing ileal conduit
    L'obiettivo principale dello studio è valutare il tasso di stenosi uretero-ileali benigne, dopo modulazione del livello di resezione degli ureteri, guidata dal verde di indocianina, durante l’eviscerazione pelvica
    E.2.2Secondary objectives of the trial
    - To assess the feasibility and safety of this technique.
    - To evaluate the incidence of ureteric leak in these patients
    - To assess the oncological outcomes in this population.
    - Valutare Valutare la fattibilità e la sicurezza di questa tecnica.
    - Valutare l’incidenza di leak ureterale in queste pazienti.
    - Valutare gli outcome oncologici di queste pazienti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >=18 years;
    - Cervical/vulvar/vaginal/endometrial cancer recurrence/progression or persistence suitable for pelvic exenteration histologically confirmed,
    - Estimated life expectancy of at least 4 weeks;
    - Signed written informed consent.
    - Età >=18 anni;
    - Recidiva/progressione oppure persistenza di tumore cervicale/vulvare/vaginale/endometriale, candidabile ad eviscerazione pelvica, dopo conferma istologica.
    - Aspettativa di vita stimata di almeno 4 settimane;
    - Firma del consenso informato scritto.
    E.4Principal exclusion criteria
    - Allergy to iodine;
    - Patients undergoing only posterior pelvic exenteration;
    - Patients undergoing ureterostomy;
    - Patients who underwent previous ureteral surgery (open, endoscopic or minimally invasive);
    - Refusal to sign written informed consent.
    - Allergia allo iodio;
    - Pazienti sottoposte solo ad eviscerazione pelvica posteriore;
    - Pazienti sottoposte a uretero-cutaneo-stomia;
    - Pazienti che hanno subito un precedente intervento chirurgico ureterale (open, laparoscopico, robotico o endoscopico);
    - Rifiuto di firmare il consenso informato scritto
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to evaluate the rate of benign uretero-enteric stricture
    L'endpoint primario dello studio è valutare il tasso di stenosi uretero-enterica benigna
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    To evaluate the rate of Clavien Dindo grade three and four post-operative complications.; To assess rate of ureteric leak in this population; To assess 12-months overall survival (OS) and progression free survival (PFS)
    Valutare il tasso di complicanze postoperatorie di grado tre e quattro di Clavien Dindo; Valutare il tasso di leak ureterali in queste pazienti.; Valutare la sopravvivenza globale (OS) a 12 mesi e la sopravvivenza libera da progressione (PFS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 month; 24 month; 12 months
    24 mesi; 24 mesi; 12 mesi
    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 No
    E.6.4Safety Yes
    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 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
    nessuno
    none
    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 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 months0
    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 months0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 practice
    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 Decision2023-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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