Ovarian CarcinomaIFFaLCCONCT02297958
Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma
An observational study of Ovarian Carcinoma, run by Rennes University Hospital at 1 site in France.
Trial summary
Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2015to 27 Jul 2019
- 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: Patient with ovarian carcinoma
Who may be able to join
- Pathological ovarian carcinoma diagnosed at pathological analysis after surgery.
- Neo adjuvant chemotherapy
Who cannot join
- no neo-adjuvant chemotherapy
- no ovarian carcinoma at final pathological analysis
- less than 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility.
- Conditions
- Ovarian Carcinoma
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response
Main outcome is cleaved FasL level and correlation with neoadjuvant chemotherapy tumor response, evaluated during surgery.
Measured: surgery
Secondary outcomes (3)
Identification of tumoral T cells
Identification of tumoral T cells with FACS analysis of dissociated tumor. Different T cells will be studies: Treg/Th17/Th1/Th2 using antibodies against: CD45/CD3/CD4/CD25/FOXP3 (Treg), CD45/CD3/CD4/IL17A (Th17), CD45/CD3/CD4/CD8/IL4/INF (TCD8 and LTCD4 Th1 et Th2).
Measured: surgery
Disease Free Survival rate
Measured: 18 months after surgery
Overall survival rate
Measured: 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study start15 Jan 2015
- Primary completion27 Jul 2019
- Study completion27 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Lavoue, PH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297958
- Sponsor's protocol ID
- 2014-A01041-46
- Acronym
- IFFaLCCO
- Status last verified
- Aug 2020
- First submitted
- 19 Nov 2014
- Last updated
- 31 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT02297958
- Acronym / sponsor ID
- IFFaLCCO / 2014-A01041-46
- Conditions
- Ovarian Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 27 Jul 2019 (actual)
- Study completion
- 27 Jul 2019 (actual)
- First posted
- 21 Nov 2014 (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.
Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with ovarian carcinoma
Key inclusion criteria (2 listed)
- Pathological ovarian carcinoma diagnosed at pathological analysis after surgery.
- Neo adjuvant chemotherapy
Key exclusion criteria (3 listed)
- no neo-adjuvant chemotherapy
- no ovarian carcinoma at final pathological analysis
- less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response
Time frame: surgery
Main outcome is cleaved FasL level and correlation with neoadjuvant chemotherapy tumor response, evaluated during surgery.
3 secondary outcomes
Identification of tumoral T cells
Time frame: surgery
Disease Free Survival rate
Time frame: 18 months after surgery
Overall survival rate
Time frame: 18 months after surgery
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 31 Aug 2020.
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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.
Vincent Lavoue, PH 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 Carcinoma, 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 3 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 31 Aug 2020. 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?
Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response (time frame: surgery). 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 31 Aug 2020.