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

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: Epithelial Ovarian Cancer
• Intervention / Treatment: Other: No intervention

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

• Study Contact: Name: Judith R Kroep, MD PhD; Phone Number: +31715263464; Email: j.r.kroep@lumc.nl
• Study Contact Backup: Name: A F de Groot, MD; Phone Number: +31715299126; Email: a.f.de_groot@lumc.nl

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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	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

Collaborators and Investigators

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

Study record dates

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: Immunity; Primary peritoneal cancer; Fallopian tube cancer; Prognostic; Epithelial ovarian cancer; EOC; Immune markers; IMPrOVE
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
• 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