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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00771-54 | Other Identifier | ANSM |
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End of recruiting period
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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This is a monocenter, interventional, non-randomized study among women patients with an ovarian or tubal cancer who will receive a surgery or adjuvant chemotherapy treatment, or a neo-adjuvant chemotherapy then surgery +/- adjuvant chemotherapy. The planned interventions are collection of biological samples at different times. The study will aim to describe the immunological profile at diagnosis in terms of phenotypic : PBMCs (peripheral blood, mononuclear cells) in peripheral blood, TILs (tumor-infiltrating lymphocytes) in ascites and in carcinomatosis.
Participants will receive the following interventions because they are enrolled in the study: blood sample collection
Two additional blood samples will be collected in each patient : one at diagnosis and one at the end of chemotherapy.
The aim of this study is to describe the immunological profile at diagnosis in terms of phenotypic : PBMC in peripheral blood, TILs in ascites and in carcinomatosis, in patients treated for peritoneal carcinomatosis of ovarian or tubal origin. The treatment has to be a surgery and an adjuvant chemotherapy, or a neo-adjuvant chemotherapy followed by a surgery +/- adjuvant chemotherapy.
Other objectives of the study include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood sample collection | Experimental | Participants will receive the following interventions because they are enrolled in the study: blood sample collection
Intervention : Collection of two blood samples (5mL)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Procedure | Participants will receive the following interventions because they are enrolled in the study: blood sample collection
|
| Measure | Description | Time Frame |
|---|---|---|
| Counting of lymphocyte populations (pre-chemotherapy) | For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), before chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint | At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment) |
| Counting of lymphocyte populations (post-chemotherapy) | For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), at the end of chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint | At the end of chemotherapy (post-CT), up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histological type on the initial biopsy | To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC) | At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment |
| Clinical response to chemotherapy (post-chemotherapy) |
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Inclusion Criteria:
Exclusion Criteria:
Women in a study of ovarian cancer
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| Name | Affiliation | Role |
|---|---|---|
| Delphine Hudry, MD | Département de cancérologie uro-digestive - Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | France | 59020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29545564 | Background | Bobisse S, Genolet R, Roberti A, Tanyi JL, Racle J, Stevenson BJ, Iseli C, Michel A, Le Bitoux MA, Guillaume P, Schmidt J, Bianchi V, Dangaj D, Fenwick C, Derre L, Xenarios I, Michielin O, Romero P, Monos DS, Zoete V, Gfeller D, Kandalaft LE, Coukos G, Harari A. Sensitive and frequent identification of high avidity neo-epitope specific CD8 + T cells in immunotherapy-naive ovarian cancer. Nat Commun. 2018 Mar 15;9(1):1092. doi: 10.1038/s41467-018-03301-0. | |
| 29754820 |
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|
In patients receiving neo-adjuvant chemotherapy, clinical response to chemotherapy defined by a partial or complete radiological response (assessed on the thoraco-abdominopelvic CT scan), associated with a decrease in CA125 and a disappearance of ascites in case of ascites at inclusion
| At the end of chemotherapy, up to 3 months |
| Histological response to chemotherapy (no residual disease on excised tissue) | Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy | At the surgery, an average of 6 weeks after inclusion |
| Progression-free survival | Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause | 6 months min to 14 months max |
| Global survival | Time between diagnosis and death, whatever the cause | 6 months min to 14 months max |
| Background |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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