Epithelial Ovarian CancerIMPrOVENCT03862677
Determining Prognostic Immune Markers in Patients With Ovarian Cancer
An observational study of Epithelial Ovarian Cancer, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Aug 2020to 31 Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden
Judith R Kroep, MD PhD
About this study
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).
Read the 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.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- No intervention
- Keywords
- Epithelial ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, EOC, Immunity, IMPrOVE, Prognostic, Immune markers
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with (suspicion of) primary EOC | Not described Receives: Other: No intervention | |
| Patients with recurrent EOC | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS
Measured: 5 years
Secondary outcomes (28)
Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS
Measured: 5 years
Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS
Measured: 5 years
Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS
Measured: 5 years
Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS
Measured: 5 years
Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS
Measured: 5 years
Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS
Measured: 5 years
Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS
Measured: 5 years
Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS
Measured: 5 years
Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS
Measured: 5 years
Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS
Measured: 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
Measured: 5 years
Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS
Measured: 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
Measured: 5 years
Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS
Measured: 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
Measured: 5 years
Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start15 Aug 2020
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.R. Kroep, Leiden University Medical Center
- Investigators
- Judith R Kroep, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862677
- Sponsor's protocol ID
- NL66869.058.19
- Acronym
- IMPrOVE
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2019
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided