Determining Prognostic Immune Markers in Patients With Ovarian Cancer
Recruiting
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- Other: No intervention
- Registration Number
- NCT03862677
- Lead Sponsor
- Leiden University Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with (suspicion of) primary EOC No intervention - Patients with recurrent EOC No intervention -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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 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 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 Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS 5 years Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS 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 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 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 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 Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS 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 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
Trial Locations
- Locations (1)
Leiden University Medical Center
🇳🇱Leiden, Netherlands