Clinical trial NCT03862677: Determining Prognostic Immune Markers in Patients With Ovarian Cancer
Official title: Determining Prognostic Immune Markers in Patients With Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
EOC
Immunity
IMPrOVE
Prognostic
Immune markers
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be carried out in patients with primary and recurrent EOC considered eligible for treatment with surgery, chemotherapy and/or immunotherapy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS
timeFrame: 5 years
Secondary outcomes:
measure: Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS
timeFrame: 5 years
measure: Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS
timeFrame: 5 years
measure: Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS
timeFrame: 5 years
measure: Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS
timeFrame: 5 years
measure: Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS
timeFrame: 5 years
measure: Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS
timeFrame: 5 years
measure: Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS
timeFrame: 5 years
measure: Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS
timeFrame: 5 years
measure: Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS
timeFrame: 5 years
measure: Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: 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)
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS
timeFrame: 5 years
measure: Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS
timeFrame: 5 years
measure: Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS
timeFrame: 5 years
measure: Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS
timeFrame: 5 years
measure: Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with OS
timeFrame: 5 years
measure: Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with OS
timeFrame: 5 years
measure: Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with PFS
timeFrame: 5 years
measure: Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with PFS
timeFrame: 5 years
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Judith R Kroep, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: