Ovarian CancerIClyCONCT01606358
Influence of Chemotherapy on Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer
An observational study of Ovarian Cancer, run by Rennes University Hospital at 1 site in France.
Trial summary
In patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy. The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated. 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?
- Carboplatin and / or taxol chemotherapy
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento May 2016
- 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 proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy.
Who may be able to join
- Patients with proven epithelial ovarian cancer
- Patients receiving carboplatin and / or taxol chemotherapy.
Who cannot join
- Minor patient
- Protected adult
- Lack of invasion to the final histological checking
- Absence of chemotherapy in the therapeutic plan of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IClyCO Influence of Chemotherapy (Carboplatin and Taxol) on the ex Vivo Expansion and Functional Capacity of Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer
In patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy.
The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.
The long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on Vgamma9Vdelta2 T cells.
Read the detailed description
Ovarian cancer is associated with a high mortality rate. Treatment of ovarian cancer is currently based on surgery and chemotherapy.
The first surgery is a radical surgical procedure aiming to achieve no residual disease. Patients who could not benefit from the first surgery may be offered neoadjuvant chemotherapy with a new surgical procedure after 3 or 6 chemotherapy cycles. Chemotherapy is currently based on Taxol and Carboplatin. Immunotherapy based on Vgamma9Vdelta2 T cells could provide a promising therapeutic strategy, however, the impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.
We want to study the effect of chemotherapy of ovarian cancer on Vgamma9Vdelta2 T cells rates in the peripheral blood of patients with ovarian cancer.
Functional abilities of the Vgamma9Vdelta2 T cells will be studied: expansion after chemotherapy and their cytotoxic abilities in an autologous context before or after chemotherapy.
The long term goal is to give a rational to combine conventional treatment of ovarian cancer with non-conventional treatment such as immunotherapy based on Vgamma9Vdelta2 T cells.
- Conditions
- Ovarian Cancer
- Being tested
- Carboplatin and / or taxol chemotherapy
- Keywords
- Ovarian Cancer, Patient with ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin and / or taxol chemotherapyDrug
Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy (usual care).
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Cancer | Not described Receives: Drug: Carboplatin and / or taxol chemotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Primary completionMay 2016 (estimated)
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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Laviolle, MD PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606358
- Sponsor's protocol ID
- 2011-A00214-37
- Acronym
- IClyCO
- Status last verified
- Aug 2014
- First submitted
- 23 May 2012
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IClyCO Influence of Chemotherapy (Carboplatin and Taxol) on the ex Vivo Expansion and Functional Capacity of Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01606358
- Acronym / sponsor ID
- IClyCO / 2011-A00214-37
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Patient with ovarian cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Primary completion
- May 2016 (estimated)
- First posted
- 25 May 2012 (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.
In patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy.
The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.
The long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on Vgamma9Vdelta2 T cells.
Detailed description
Ovarian cancer is associated with a high mortality rate. Treatment of ovarian cancer is currently based on surgery and chemotherapy.
The first surgery is a radical surgical procedure aiming to achieve no residual disease. Patients who could not benefit from the first surgery may be offered neoadjuvant chemotherapy with a new surgical procedure after 3 or 6 chemotherapy cycles. Chemotherapy is currently based on Taxol and Carboplatin. Immunotherapy based on Vgamma9Vdelta2 T cells could provide a promising therapeutic strategy, however, the impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.
We want to study the effect of chemotherapy of ovarian cancer on Vgamma9Vdelta2 T cells rates in the peripheral blood of patients with ovarian cancer.
Functional abilities of the Vgamma9Vdelta2 T cells will be studied: expansion after chemotherapy and their cytotoxic abilities in an autologous context before or after chemotherapy.
The long term goal is to give a rational to combine conventional treatment of ovarian cancer with non-conventional treatment such as immunotherapy based on Vgamma9Vdelta2 T cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Cancer | – | Drug: Carboplatin and / or taxol chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy.
Key inclusion criteria (2 listed)
- Patients with proven epithelial ovarian cancer
- Patients receiving carboplatin and / or taxol chemotherapy.
Key exclusion criteria (4 listed)
- Minor patient
- Protected adult
- Lack of invasion to the final histological checking
- Absence of chemotherapy in the therapeutic plan of treatment
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 |
|---|---|---|
| Carboplatin and / or taxol chemotherapyPatient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy (usual care). | Drug | Ovarian Cancer |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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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.
Bruno Laviolle, MD PhD study chair
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 4 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: withdrawn, as of the sponsor's last update on 11 Aug 2014. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 11 Aug 2014.