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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Institut Paoli-Calmettes
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01977274
First received: October 30, 2013
Last updated: December 31, 2013
Last verified: December 2013
  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: 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 ] [ Designated as safety issue: No ]
    gene expression level


Secondary Outcome Measures:
  • relation between molecular alteration and clinical and histological characteristics [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gynecological cancer
  • age > 18
  • signed informed consent

Exclusion Criteria:

- emergency

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977274

Contacts
Contact: Agnès BOYER CHAMMARD 33491223778 drci.up@ipc.unicancer.fr

Locations
France
Institut Paoli Calmettes Recruiting
Marseille, France, 13 009
Contact: Agnes BOYER CHAMMARD, MD         
Principal Investigator: Eric LAMBAUDIE, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01977274     History of Changes
Other Study ID Numbers: GC-BIO-IPC 2013-010
Study First Received: October 30, 2013
Last Updated: December 31, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 28, 2014