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NCT Number: NCT03862677

Determining Prognostic Immune Markers in Patients With Ovarian Cancer

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).

Recruiting

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Leiden University Medical Center

Leiden, Netherlands

Location status: Recruiting

Location contact

Judith R Kroep, MD PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Observational study, no intervention

Primary outcomes

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

    Time frame: 5 years

Secondary outcomes

  1. Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS

    Time frame: 5 years

  2. Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS

    Time frame: 5 years

  3. Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS

    Time frame: 5 years

  4. Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS

    Time frame: 5 years

  5. Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS

    Time frame: 5 years

  6. Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS

    Time frame: 5 years

  7. Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS

    Time frame: 5 years

  8. Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS

    Time frame: 5 years

  9. Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS

    Time frame: 5 years

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

Study contacts

Contact information is provided by the study sponsor or research team.

A F de Groot, MD

CONTACT

[email protected]

+31715299126

Judith R Kroep, MD PhD

CONTACT

[email protected]

+31715263464

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: IMPrOVE

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2019
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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