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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
419

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Bergonie
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil - CHI Créteil
      • Dijon, France, 21079
        • Centre Georges Francois 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 - René 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Tumor biopsies
Tumor biopsies will be performed before and after treatment.
Procedure: Blood sampling
Blood sampling will be performed before and after treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Curie

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IC 2013-02 BIO-RAIDs

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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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