Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer

Ovarian Cancer Stage IV Clinical Trial

— TILsOV-1805  

Official title:

Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03922776
• Other study ID #: TILsOV-1805
• Secondary ID: Id RCB
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Participants will receive the following interventions because they are enrolled in the study:

blood sample collection

• at diagnosis, before chemotherapy (pre-CT)

• after chemotherapy (post-ct)

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:

• Evaluate the association between the immunological profile at diagnosis and the characteristics of the disease at diagnosis (histological type, extension)

• Evaluate the prognostic value of the immunological profile at diagnosis in terms of clinical response to neoadjuvant chemotherapy (for patients with interval surgery)

• Evaluate the polarization of the immune response induced by chemotherapy, describing the phenotypic changes in the different types of samples (blood, +/- ascites, +/- carcinomatosis) after chemotherapy in comparison with samples at diagnostic

• Evaluate the association between these immunological phenotypic changes and the clinical response to chemotherapy in patients receiving neoadjuvant chemotherapy

• Collect biological material for peritoneal carcinomatosis for subsequent biological analyzes

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: May 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or more

• Presenting a carcinomatosis with suspicion of ovarian cancer or tubal cancer, under a diagnostic laparoscopy

• Stage IIIC or initial pleural IV

• Planned treatment with surgery and adjuvant chemotherapy, or neo-adjuvant chemotherapy followed by surgery +/- adjuvant chemotherapy

• Having been informed and signed the informed consent of this study

• Affiliated with a social security scheme

Exclusion Criteria:

• Stage IV with visceral metastases (pulmonary, hepatic ...)

• Contraindication to surgery and / or chemotherapy

• Pregnant or lactating woman

• Patient under guardianship or curatorship

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer Stage IIIC
• Fallopian Tube Cancer Stage IV
• Fallopian Tube Neoplasms
• Ovarian Cancer Stage IIIC
• Ovarian Cancer Stage IV
• Ovarian Neoplasms

Intervention

Procedure:
• Blood sample collection
Participants will receive the following interventions because they are enrolled in the study: blood sample collection at diagnosis, before chemotherapy (pre-CT) after chemotherapy (post-ct) Collection of two blood samples (5mL), before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment and then, after chemotherapy (post-CT), up to 3 months after enrollment

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Secondary	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
Secondary	Clinical response to chemotherapy (post-chemotherapy)	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
Secondary	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
Secondary	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
Secondary	Global survival	Time between diagnosis and death, whatever the cause	6 months min to 14 months max