Predictive Clinical and Biological Parameters in Gynecological Cancer (GC-BIO)

June 30, 2020 updated by: Institut Paoli-Calmettes

Predictive Clinical and Biological Parameters in Gynecological Cancer - GC-BIO-IPC 2013-010

Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

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 Contact

Study Locations

  • France
      • Marseille, France, 13 009
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
        • Principal Investigator:
          • Eric Lambaudie, MD

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:

  • gynecological cancer suspicion
  • age > 18
  • signed informed consent

Exclusion Criteria:

- emergency

Exclusion criteria after histological exam Any diagnosis that is not a gynecological cancer (ovarian, cervix, endometrium).

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
Experimental: gynecological cancer
blood and tumor samples
Other: gynecological cancer
blood and tumor samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
molecular alteration in gynecological cancer
Time Frame: average of 4 weeks after diagnosis
gene expression level
average of 4 weeks after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relation between molecular alteration and clinical and histological characteristics
Time Frame: up to 10 years
hazard ratio between molecular alteration and clinico-histological characteristics
up to 10 years

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

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.

Helpful Links

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

December 1, 2013

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2033

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC-BIO-IPC 2013-010

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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