Determining prognostic immune markers in patients with ovarian cancer * a prospective explorative cohort study.

Determining prognostic immune markers in patients with ovarian cancer * a prospective explorative cohort study. - IMPrOVE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48676

Enrollment

300

Registered

2019-06-21

Start date

2020-08-21

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS.	—

Secondary

Measure	Time frame
* Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS. * Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS/OS. * Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS/OS. * Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary and recurrent EOC and PFS/OS. * Composition/counts and function of myeloid cells in PBMCs in patients with primary and recurrent EOC before and during treatment and the association with PFS/OS. * Influence of the mMDSC/DC ratio and separate immune cell populations on the tumor specific and general immune response. * Determined, optimized and validated optimal cut-off point for the macrophage/DC ratio and the mMDSC/DC ratio in PBMCs in patients with primary and recurrent EOC for the different chemotherapeutic and immunotherapeutic treatment modalities. * Immune contexture of primary and recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS/OS. * Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary and recurrent EOC and the association with PFS/OS.	—

Measure

Time frame

* Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS. * Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS/OS. * Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS/OS. * Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary and recurrent EOC and PFS/OS. * Composition/counts and function of myeloid cells in PBMCs in patients with primary and recurrent EOC before and during treatment and the association with PFS/OS. * Influence of the mMDSC/DC ratio and separate immune cell populations on the tumor specific and general immune response. * Determined, optimized and validated optimal cut-off point for the macrophage/DC ratio and the mMDSC/DC ratio in PBMCs in patients with primary and recurrent EOC for the different chemotherapeutic and immunotherapeutic treatment modalities. * Immune contexture of primary and recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS/OS. * Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary and recurrent EOC and the association with PFS/OS.

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Countries

Netherlands

Outcome results