Influence of Chemotherapy on Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer (IClyCO)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 23, 2012 | ||||
| Last Updated Date | December 3, 2012 | ||||
| Start Date ICMJE | May 2012 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01606358 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Influence of Chemotherapy on Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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. 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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: The VGAMMA9VDELTA2 T cells will be isolated from peripheral blood mononuclear cells of patients with ovarian cancer. |
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy. |
||||
| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE | Drug: Carboplatin and / or taxol chemotherapy
Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy (usual care). |
||||
| Study Group/Cohort (s) | Ovarian Cancer
Intervention: Drug: Carboplatin and / or taxol chemotherapy |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01606358 | ||||
| Other Study ID Numbers ICMJE | 2011-A00214-37 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rennes University Hospital | ||||
| Study Sponsor ICMJE | Rennes University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Rennes University Hospital | ||||
| Verification Date | December 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||