Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors (ABT737 exvivo)

This study has been completed.
Sponsor:
Collaborator:
GRECAN
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01440504
First received: September 15, 2011
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.


Condition Intervention Phase
Ovarian Cancer
Other: culture ex vivo with exposure to different therapeutic agents alone or in combination.
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • rate of apoptotic cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: April 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: culture ex vivo with exposure to different therapeutic agents alone or in combination.
    When tumor resection, tumor specimens of ovarian cancer will be made ​​towards a culture ex vivo with exposure to different therapeutic agents alone or in combination.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient, any chemotherapy naive or ovarian surgery, ovarian cancer with at least five tumor samples does not affect the diagnostic

Criteria

Inclusion Criteria:

  • Patient aged over 18 years
  • Ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses
  • Surgery of any initial chemotherapy naive
  • Patient information and signed informed consent

Exclusion Criteria:

  • A person deprived of liberty or under guardianship
  • Insufficient tumor samples of ovarian cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440504

Locations
France
Centre François Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
GRECAN
Investigators
Principal Investigator: JOLY Florence, Pr Centre françois Baclesse
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01440504     History of Changes
Other Study ID Numbers: ABT-737 ex vivo
Study First Received: September 15, 2011
Last Updated: February 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
Cancer
Ovarian
chemotherapy
BH3-mimetic
platin
ex-vivo

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

ClinicalTrials.gov processed this record on April 16, 2014