NCT01440504

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

September 15, 2011

Last Update Submit

February 6, 2013

Conditions

Ovarian Cancer

Keywords

CancerOvarianchemotherapyBH3-mimeticplatinex-vivo

Outcome Measures

Primary Outcomes (1)

  • rate of apoptotic cells

    2 years

Interventions

culture ex vivo with exposure to different therapeutic agents alone or in combination.OTHER

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 Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • A person deprived of liberty or under guardianship
  • Insufficient tumor samples of ovarian cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François Baclesse

Caen, 14076, France

Location

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • JOLY Florence, Pr

    Centre françois Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 26, 2011

Study Start

April 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

FR(1)