- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02878122
Study of Predictive Factors of Chemoresistance in Ovarian Cancer (FaCliBioCCo)
August 16, 2021 updated by: Rennes University Hospital
Epithelial ovarian cancer (EOC) has a poor prognosis.
EOC management requires debulking surgery and chemotherapy based on taxol and carboplatine.
Initial response is often good, but most often a recurrence occurred in the first 18 months.
Early recurrence signs chemoresistance and palliative treatment.
The study of predictive clinical or biological factors is required to adapt therapeutic and develop new treatments.
Study Overview
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rennes, France
- LAVOUE
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients with epithelial ovarian cancer
Description
Inclusion Criteria:
- patient > 18 years of age
- patient with histological proven epithelial ovarian cancer
Exclusion Criteria:
- patients who can not give their own consent
- patients without ovarian cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with epithelial ovarian cancer
Cancer treatment
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Chemotherapy and laparoscopic surgery
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chemoresistance defined by clinical recurrence
Time Frame: 6 months after the end of chemotherapy
|
6 months after the end of chemotherapy
|
|
Chemoresistance defined by biological recurrence
Time Frame: 6 months after the end of chemotherapy
|
6 months after the end of chemotherapy
|
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Chemoresistance defined by radiological recurrence
Time Frame: 6 months after the end of chemotherapy
|
6 months after the end of chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: LAVOUE Vincent, Pr, Rennes University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
August 22, 2016
First Submitted That Met QC Criteria
August 24, 2016
First Posted (Estimate)
August 25, 2016
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 16, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Antineoplastic Agents
- Carboplatin
Other Study ID Numbers
- 35RC15_3007_FaCliBioCCo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.