Determining Prognostic Immune Markers in Patients With Ovarian Cancer (IMPrOVE)

February 12, 2026 updated by: J.R. Kroep, Leiden University Medical Center
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Recruiting
        • Leiden University Medical Center
        • Contact:
          • Judith R Kroep, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with (suspicion of) primary EOC
Other: No intervention
Observational study, no intervention
Patients with recurrent EOC
Other: No intervention
Observational study, no intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS
Time Frame: 5 years
5 years
Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS
Time Frame: 5 years
5 years
Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS
Time Frame: 5 years
5 years
Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS
Time Frame: 5 years
5 years
Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS
Time Frame: 5 years
5 years
Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS
Time Frame: 5 years
5 years
Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS
Time Frame: 5 years
5 years
Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS
Time Frame: 5 years
5 years
Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS
Time Frame: 5 years
5 years
Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS
Time Frame: 5 years
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
Time Frame: 5 years
5 years
Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS
Time Frame: 5 years
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
Time Frame: 5 years
5 years
Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS
Time Frame: 5 years
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
Time Frame: 5 years
5 years
Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS
Time Frame: 5 years
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
Time Frame: 5 years
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)
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Investigators

  • Principal Investigator: Judith R Kroep, MD PhD, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL66869.058.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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