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

Primary Purpose

Ovarian Cancer, Endometrium Cancer, Cervix Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

gynecological cancer

About this trial

This is an interventional basic science trial for Ovarian Cancer focused on measuring ovarian, endometrium, cervix cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Institut Paoli CalmettesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gynecological cancer

Arm Description

blood and tumor samples

Outcomes

Primary Outcome Measures

molecular alteration in gynecological cancer

gene expression level

Secondary Outcome Measures

relation between molecular alteration and clinical and histological characteristics

hazard ratio between molecular alteration and clinico-histological characteristics

Full Information

NCT ID

NCT01977274

First Posted

October 30, 2013

Last Updated

June 30, 2020

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT01977274

Brief Title

Predictive Clinical and Biological Parameters in Gynecological Cancer

Acronym

GC-BIO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Recruiting

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Endometrium Cancer, Cervix Cancer

Keywords

ovarian, endometrium, cervix cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

gynecological cancer

Arm Type

Experimental

Arm Description

blood and tumor samples

Intervention Type

Other

Intervention Name(s)

gynecological cancer

Intervention Description

blood and tumor samples

Primary Outcome Measure Information:

Title

molecular alteration in gynecological cancer

Description

gene expression level

Time Frame

average of 4 weeks after diagnosis

Secondary Outcome Measure Information:

Title

relation between molecular alteration and clinical and histological characteristics

Description

hazard ratio between molecular alteration and clinico-histological characteristics

Time Frame

up to 10 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominique GENRE, MD

Phone

33491223778

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Margot BERLINE, MSc, MBA

Phone

33491223778

drci.up@ipc.unicancer.fr

Facility Information:

Facility Name

Institut Paoli Calmettes

City

Marseille

ZIP/Postal Code

13 009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dominique GENRE, MD

Phone

33491223778

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Margot BERLINE, MSc, MBA

Phone

33491223778

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Eric LAMBAUDIE, MD

12. IPD Sharing Statement

Links:

URL

http://www.institutpaolicalmettes.fr

Description

official web site of the sponsor

Learn more about this trial

Predictive Clinical and Biological Parameters in Gynecological Cancer

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