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    The EU Clinical Trials Register currently displays   37236   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-002623-15
    Sponsor's Protocol Code Number:GS11/9681
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-03-07
    Trial results View 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 ConcernedIreland - HPRA
    A.2EudraCT number2012-002623-15
    A.3Full title of the trial
    GLiSten: Next generation intraoperative lymph node staging for stratified colon cancer surgery- Development Phase
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    5-ALA in Bowel Cancer Surgery
    A.3.2Name or abbreviated title of the trial where available
    GLiSten: 5-ALA in Bowel Cancer Surgery - Development Phase
    A.4.1Sponsor's protocol code numberGS11/9681
    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 SponsorUniversity of Leeds
    B.1.3.4CountryUnited Kingdom
    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 supportEfficacy and Mechanism Evaluation Programme - National Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Research Unit
    B.5.2Functional name of contact pointCatherine Lowe
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Leeds
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS29NG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441133431494
    B.5.5Fax number+441133434345
    B.5.6E-mailc.m.lowe@leeds.ac.uk
    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 Gliolan
    D.2.1.1.2Name of the Marketing Authorisation holderMedac GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGliolan
    D.3.4Pharmaceutical form Powder for oral solution
    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 INN5-aminolevulinic acid (5-ALA)
    D.3.9.1CAS number 5451-09-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 30
    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 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 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
    Colon cancer
    E.1.1.1Medical condition in easily understood language
    Bowel cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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
    To optimise the dose of oral 5-ALA administration for intra-operative fluorescence diagnosis of metastatic lymph nodes in colon cancer.
    E.2.2Secondary objectives of the trial
    1) Establish a reliable and repeatable methodology for fluorescence diagnosis of lymph node metastasis by standardisation of:
    i) pre-operative CT lymph node reporting
    ii) intra-operative fluorescence detection system
    iii) surgical technique for laparoscopic segmental colonic resection with D3 lymphadenectomy
    iv) histopathogical examination of resected specimens.
    2) identify systemic, operative and patient factors which adversely affect the intraoperative detection of lymph node fluorescence.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to give informed consent and willing to follow trial protocol
    2. Aged over 18
    3. Patients with cancers of the right and sigmoid colon amenable to laparoscopic resection incorporating D3 lymphadenectomy, as agreed by MDT discussion following histopathological diagnosis and radiological staging. Where possible, the study population will be enriched with locally advanced colon cancers to obtain as much information as possible on 5-ALA FD for lymph node metastases.
    4. Patients with distant metastatic disease will be eligible, provided laparoscopic resection of the cancer is part of routine clinical care.
    5. Fit for standard laparoscopic resection
    6. American Society of Anesthesiologists (ASA) classification ≤ 3
    7. Normal hepatic and renal function on most recent blood tests (to be within 30 days prior to surgery). For the purposes of the trial a normal hepatic renal function can be defined as:
    i) Total bilirubin within normal institutional limits,
    ii) AST/ALT < 2.5 X institutional upper limit of normal
    ii) GFR > or = 60mls/min/1.73m2 or Creatinine within 10% of upper value for normal institutional limits.

    Evaluation phase: a separate protocol and application will be submitted
    E.4Principal exclusion criteria
    1. Patients with cancers of the transverse and left colon (due to difficulty in defining D3 lymphadenectomy in these anatomical locations)
    2. Past history of hypersensitivity reactions to 5-ALA or colorimetric dye.
    3. Acute or chronic porphyria or a family history
    4. Patients with synchronous colonic or rectal cancer (but not benign polyps)
    5. Patients with co-existent inflammatory bowel disease, such as Crohn’s disease, ulcerative colitis or active diverticulitis, which may influence the lymphatic uptake of 5-ALA
    6. Pregnant (positive pregnancy test) or breast feeding. 5-ALA has unknown teratogenic and abortifacient effects.
    In women of childbearing potential (defined as any female who has experienced menarche and who is not postmenopausal or permanently sterilised e.g. tubal occlusion, hysterectomy, bilateral salpingectomy), a pregnancy test will be performed and evidence of a negative result will be required prior to entry into the study. In females of child bearing potential, or those patients with partners of child bearing potential, trial investigators will advise on appropriate contraception (e.g. barrier method) from the point of registration to 30 days postop.
    7. Received an investigational medicinal product at any dose within 28 days before registration
    8. Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial.
    Where possible, the study population will be enriched with locally advanced colon cancers (CT findings of a T4 tumour, T3 tumours with and extramural depth of > 5mm, as per FOcTROT definition) to obtain as much information as possible on 5ALA for lymph node metastases.
    Concerns regarding a patient's eligibility can be discussed with the St John's University Hospital Leeds' Research Fellow, or with the Chief Investigator.


    [Evaluation phase: a separate protocol and application will be submitted]
    E.5 End points
    E.5.1Primary end point(s)
    We aim to undertake a two-staged investigation

    Developmental Phase: Identification of the optimal dose for oral administration of 5-ALA for the accurate intra-operative detection of lymph node metastases.
    Evaluation Phase: a separate protocol and application will be submitted for this phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both centres will recruit at least 20 patients over a period of 18 months
    E.5.2Secondary end point(s)
    1) Establish a reliable and repeatable methodology for fluorescence diagnosis of lymph node metastasis by standardisation of:
    i) pre-operative CT lymph node reporting
    ii) intra-operative fluorescence detection system
    iii) surgical technique for laparoscopic segmental colonic resection with D3 lymphadenectomy
    iv) histopathogical examination of resected specimens.
    2) identify systemic, operative and patient factors which adversely affect the intraoperative detection of lymph node fluorescence.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Both centres will recruit at least 20 patients over a period of 18 months
    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 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 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 No
    E.8.1.2Open No
    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 No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Yes
    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
    The end of the trial is defined as the date all histopathology results from resected samples have been evaluated or the end of the period of serious adverse event notification, that is 30 days after the last participant has received 5 ALA.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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)
    None (not applicable). The surgical intervention is a one-off procedure. Patients will continue to have routine clinical follow up as per local standard practice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-08-07
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