Determining Prognostic Immune Markers in Patients With Ovarian Cancer

Study Overview
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Brief Summary
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The IMPRoVE study is a prospective, non-interventional, explorative cohort study to determine prognostic immune markers in patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (EOC).

Detailed Description
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Tumor material, ascites (if possible) and blood samples for immune monitoring will be collected from patients with primary and recurrent EOC undergoing surgery, chemotherapy and/or immunotherapy.

Official Title
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Determining Prognostic Immune Markers in Patients With Ovarian Cancer

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with (suspicion of) primary or recurrent EOC with an indication for surgery, chemotherapy and/or immunotherapy. Age ≥18 years. WHO performance status 0-2. Accessible for treatment and follow-up. Written informed consent. Exclusion Criteria: Other active malignancy in past 5 years prior to entry into the study, except for treated non-melanoma skin cancer. Any known severe infection like HIV, hepatitis A, B and C. Receiving immune suppressive treatment. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with (suspicion of) primary EOC<br> | Other: No intervention<br>* Observational study, no intervention<br>|
| Patients with recurrent EOC<br> | Other: No intervention<br>* Observational study, no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS |  | 5 years | 
| Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS |  | 5 years | 
| Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS |  | 5 years | 
| Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS |  | 5 years | 
| Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS |  | 5 years | 
| Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS |  | 5 years | 
| Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS |  | 5 years | 
| Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS |  | 5 years | 
| Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS |  | 5 years | 
| Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS |  | 5 years | 
| Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with primary EOC before and during treatment and the association with OS |  | 5 years | 
| Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS |  | 5 years | 
| Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with recurrent EOC before and during treatment and the association with OS |  | 5 years | 
| Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS |  | 5 years | 
| Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with primary EOC before and during treatment and the association with PFS |  | 5 years | 
| Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS |  | 5 years | 
| Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS |  | 5 years | 
| Influence of the mMDSC/DC ratio and separate immune cell populations on the tumor specific and general immune response (assessed by mixed lymphocyte reaction, functional suppression assay and lymphocyte stimulation test) |  | 5 years | 
| Determined, optimized and validated optimal cut-off point for the macrophage/DC ratio and the mMDSC/DC ratio in PBMCs in patients with primary EOC for the different chemotherapeutic and immunotherapeutic treatment modalities |  | 5 years | 
| Determined, optimized and validated optimal cut-off point for the macrophage/DC ratio and the mMDSC/DC ratio in PBMCs in patients with recurrent EOC for the different chemotherapeutic and immunotherapeutic treatment modalities |  | 5 years | 
| Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS |  | 5 years | 
| Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS |  | 5 years | 
| Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS |  | 5 years | 
| Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS |  | 5 years | 
| Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with OS |  | 5 years | 
| Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with OS |  | 5 years | 
| Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with PFS |  | 5 years | 
| Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with PFS |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epithelial ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, EOC, Immunity, IMPrOVE, Prognostic, Immune markers