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

This study is currently recruiting participants.
Verified June 2017 by Institut Paoli-Calmettes
Sponsor:
ClinicalTrials.gov Identifier:
NCT01977274
First Posted: November 6, 2013
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Paoli-Calmettes
  Purpose
Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation

Condition Intervention
Ovarian Cancer Endometrium Cancer Cervix Cancer Other: gynecological cancer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Predictive Clinical and Biological Parameters in Gynecological Cancer - GC-BIO-IPC 2013-010

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • molecular alteration in gynecological cancer [ Time Frame: average of 4 weeks after diagnosis ]
    gene expression level


Secondary Outcome Measures:
  • relation between molecular alteration and clinical and histological characteristics [ Time Frame: up to 10 years ]
    hazard ratio between molecular alteration and clinico-histological characteristics


Estimated Enrollment: 300
Study Start Date: December 2013
Estimated Study Completion Date: December 2028
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gynecological cancer
blood and tumor samples
Other: gynecological cancer
blood and tumor samples

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977274


Contacts
Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr
Contact: Isabelle BOQUET, PhD 33491223778 drci.up@ipc.unicancer.fr

Locations
France
Institut Paoli Calmettes Recruiting
Marseille, France, 13 009
Contact: Dominique GENRE, MD    33491223778    drci.up@ipc.unicancer.fr   
Contact: Isabelle BOQUET, PhD    33491223778    drci.up@ipc.unicancer.fr   
Principal Investigator: Eric LAMBAUDIE, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
  More Information

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01977274     History of Changes
Other Study ID Numbers: GC-BIO-IPC 2013-010
First Submitted: October 30, 2013
First Posted: November 6, 2013
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Institut Paoli-Calmettes:
ovarian, endometrium, cervix cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female