Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4) (BIO-RAIDs)

January 19, 2023 updated by: Institut Curie
Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

419

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Institut de Cancérologie de l'Ouest - Paul Papin
      • Bordeaux, France
        • Institut Bergonié
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil - CHI Créteil
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Lyon, France
        • Centre Léon Bérard
      • Montpellier, France, 34298
        • Institut Régional du Cancer de Montpellier - Val D'Aurelle
      • Nancy, France
        • Institut de Cancérologie de Lorraine - ICL
      • Nantes, France
        • Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Hopital Tenon
      • Paris, France, 75248
        • Insitut Curie
      • Saint-Cloud, France
        • Institut René Huguenin
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Vandœuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine- ICL NANCY
      • Villejuif, France, 94805
        • Institut de Cancérologie Gustave roussy
    • Ile De France
      • Paris, Ile De France, France, 75877
        • Groupe Hospitalier Bichat
  • Germany
      • Hannover, Germany, 30625
        • Mhh Hanover - Hanover Medical School
  • Netherlands
      • Amsterdam, Netherlands, 1006 BE
        • Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)
    • Meibergdreef
      • Amsterdam, Meibergdreef, Netherlands, 91105 AZ
        • Amsterdam Medical Center (AMC)
  • Romania
      • Brasov, Romania, 500091
        • Teo Health S.A. - Spitalul Sf. Constantin
      • Oradea, Romania, 410469
        • Spitalul Clinic Municipal "Gavril Curteanu"
      • Timisoara, Romania, 300041
        • Clinica de radioterapie
  • Serbia
      • Sremska Kamenica, Serbia, 21204
        • Clinic for operative oncology, Institute of oncology of Vojvodina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tumor biopsies and blood sampling

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.

Tumor biopsies will be performed before and after treatment.
Blood sampling will be performed before and after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between tumor biological profile and treatment response.
Time Frame: up to 6 months
Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival evaluation
Time Frame: up to 18 months
Number of patient with no local/metastasis relapse 18 months after end of primary treatment course.
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)
Time Frame: up to six months

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)
Time Frame: up to 6 months
Description of standard treatment's side effects will be assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale
up to 6 months
Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)
Time Frame: up to 24 months
Description of molecular tumor alterations regarding geographic location (country)
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2013

Primary Completion (Actual)

November 21, 2018

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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