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

Lead Sponsor: Institut Curie

Source Institut Curie
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 July 2013
Completion Date December 2019
Primary Completion Date July 2019
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: Tumor biopsies

Description: Tumor biopsies will be performed before and after treatment.

Arm Group Label: Tumor biopsies and blood sampling

Intervention Type: Procedure

Intervention Name: Blood sampling

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

France

Germany

Netherlands

Romania

Serbia

Verification Date

October 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Tumor biopsies and blood sampling

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.

Acronym BIO-RAIDs
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov