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

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ClinicalTrials.gov Identifier: NCT01977274
Recruitment Status : Recruiting
First Posted : November 6, 2013
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Endometrium Cancer Cervix Cancer Other: gynecological cancer Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Study Start Date : December 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: gynecological cancer
blood and tumor samples
Other: gynecological cancer
blood and tumor samples



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


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



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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).


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

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01977274     History of Changes
Other Study ID Numbers: GC-BIO-IPC 2013-010
First Posted: November 6, 2013    Key Record Dates
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