Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
Sponsors
Source
Institut Curie
Oversight Info
Has Dmc
No
Brief Summary
Prospective Multicentric European trial for Cervical cancer, not previously treated, with
tumour biopsies, and blood collection for molecular analysis at predetermined time points.
Overall Status
Active, not recruiting
Start Date
2013-07-01
Completion Date
2019-07-01
Primary Completion Date
2019-07-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Correlation between tumor biological profile and treatment response. |
up to 6 months |
Secondary Outcome
Measure |
Time Frame |
|
Progression Free Survival evaluation |
up to 18 months |
|
Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country) |
up to six months |
|
Standard treatment's side effects description (assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale - National Cancer Institute Common Toxicity Criteria for Adverse Effects) |
up to 6 months |
|
Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country) |
up to 24 months |
Enrollment
419
Condition
Intervention
Intervention Type
Procedure
Intervention Name
Description
Tumor biopsies will be performed before and after treatment.
Arm Group Label
Tumor biopsies and blood sampling
Intervention Type
Procedure
Intervention Name
Description
Blood sampling will be performed before and after treatment.
Arm Group Label
Tumor biopsies and blood sampling
Eligibility
Criteria
Inclusion Criteria:
1. No prior treatment for cervical cancer.
2. FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type).
3. Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and
optional for IB1 stage
4. Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more).
5. Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment).
6. Age ≥ 18 years.
7. ECOG (Eastern Cooperative Oncology Group) 0-2.
8. Life expectancy > 6 months.
9. Patient eligible for standard treatment (according to standards of each center).
10. Patient having health care insurance.
11. Informed and signed consent by patient.
(DICOM = Digital Imaging and Communications in Medicine)
Exclusion Criteria:
1. Patient enrolled in a clinical trial involving an investigative new agent.
2. Co morbidity, preventing patient to tolerate the proposed standard treatment.
3. Past history of invasive cancer over the 5 years preceding entry in the present trial
(except basal cell carcinoma and carcinoma in situ of the cervix).
4. Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker,
metallic implant, non availability, other), ), if FIGO ≥ IB2 .
5. Patient deprived from ability to decide on her own.
6. Patient unable to have a regular follow up for geographical, social or psychological
reasons.
7. Pregnancy or patient old enough to procreate and not using effective contraceptive
method.
Gender
Female
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Location
Facility |
|
Groupe Hospitalier Bichat Paris Ile De France 75877 France |
|
Institut de Cancérologie de l'Ouest - Paul Papin Angers 49933 France |
|
Institut Bergonié Bordeaux France |
|
Centre Hospitalier Intercommunal de Créteil - CHI Créteil Créteil 94010 France |
|
Centre Georges Francois Leclerc Dijon 21079 France |
|
Centre Léon Bérard Lyon France |
|
Institut Régional du Cancer de Montpellier - Val D'Aurelle Montpellier 34298 France |
|
Institut de Cancérologie de Lorraine - ICL Nancy France |
|
Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU Nantes France |
|
Centre Antoine Lacassagne Nice 06189 France |
|
Hopital Europeen Georges Pompidou Paris 75015 France |
|
Insitut Curie Paris 75248 France |
|
Hôpital Tenon Paris France |
|
Institut René Huguenin Saint-Cloud France |
|
Centre Paul Strauss Strasbourg 67065 France |
|
Institut de Cancérologie de Lorraine- ICL NANCY Vandœuvre-lès-Nancy 54519 France |
|
Institut de Cancerologie Gustave Roussy Villejuif 94805 France |
|
Mhh Hanover - Hanover Medical School Hannover 30625 Germany |
|
Amsterdam Medical Center (AMC) Amsterdam Meibergdreef 91105 AZ Netherlands |
|
Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL) Amsterdam 1006 BE Netherlands |
|
Teo Health S.A. - Spitalul Sf. Constantin Brasov 500091 Romania |
|
Spitalul Clinic Municipal "Gavril Curteanu" Oradea 410469 Romania |
|
Clinica de radioterapie Timisoara 300041 Romania |
|
Clinic for operative oncology, Institute of oncology of Vojvodina Sremska Kamenica 21204 Serbia |
Location Countries
Country
France
Germany
Netherlands
Romania
Serbia
Verification Date
2018-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
Tumor biopsies and blood sampling
Arm Group Type
Other
Description
Patient will undergo standard care with tumor and blood sampling before and after treatment.
Blood and tumor sampling will also be performed at disease progression/relapse.
Firstreceived Results Date
N/A
Acronym
BIO-RAIDs
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)
Study First Submitted
February 10, 2015
Study First Submitted Qc
April 23, 2015
Study First Posted
April 29, 2015
Last Update Submitted
April 6, 2018
Last Update Submitted Qc
April 6, 2018
Last Update Posted
April 9, 2018
ClinicalTrials.gov processed this data on August 23, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.