Ovarian CancerFaCliBioCCoNCT02878122
Study of Predictive Factors of Chemoresistance in Ovarian Cancer
An observational study of Ovarian Cancer, run by Rennes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Cancer treatment
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with epithelial ovarian cancer
Who may be able to join
- patient > 18 years of age
- patient with histological proven epithelial ovarian cancer
Who cannot join
- patients who can not give their own consent
- patients without ovarian cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ovarian Cancer
- Being tested
- Cancer treatment
- Keywords
- ovarian cancer, chemo resistance, predictive factors, cohort study, bio bank
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer treatmentProcedure or surgery
Also called Carboplatin, Taxol
Chemotherapy and laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with epithelial ovarian cancer | Cancer treatment Receives: Procedure: Cancer treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemoresistance defined by clinical recurrence
Measured: 6 months after the end of chemotherapy
Chemoresistance defined by biological recurrence
Measured: 6 months after the end of chemotherapy
Chemoresistance defined by radiological recurrence
Measured: 6 months after the end of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAVOUE Vincent, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878122
- Sponsor's protocol ID
- 35RC15_3007_FaCliBioCCo
- Acronym
- FaCliBioCCo
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2016
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Predictive Factors of Chemoresistance in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02878122
- Acronym / sponsor ID
- FaCliBioCCo / 35RC15_3007_FaCliBioCCo
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, chemo resistance, predictive factors, cohort study, bio bank
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with epithelial ovarian cancer | – | Procedure: Cancer treatmentCancer treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epithelial ovarian cancer
Key inclusion criteria (2 listed)
- patient > 18 years of age
- patient with histological proven epithelial ovarian cancer
Key exclusion criteria (2 listed)
- patients who can not give their own consent
- patients without ovarian cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer treatmentAlso: Carboplatin, TaxolChemotherapy and laparoscopic surgery | Procedure or surgery | Patients with epithelial ovarian cancer |
Primary outcome
Chemoresistance defined by clinical recurrence
Time frame: 6 months after the end of chemotherapy
Chemoresistance defined by biological recurrence
Time frame: 6 months after the end of chemotherapy
Chemoresistance defined by radiological recurrence
Time frame: 6 months after the end of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAVOUE Vincent, Pr principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemoresistance defined by clinical recurrence (time frame: 6 months after the end of chemotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.