NCT03862677

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Aug 2020Jan 2027

First Submitted

Initial submission to the registry

February 26, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

6.5 years

First QC Date

February 26, 2019

Last Update Submit

February 12, 2026

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial ovarian cancerFallopian tube cancerPrimary peritoneal cancerEOCImmunityIMPrOVEPrognosticImmune markers

Outcome Measures

Primary Outcomes (1)

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

    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

    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

  • +23 more secondary outcomes

Study Arms (2)

Patients with (suspicion of) primary EOC

Other: No intervention

Patients with recurrent EOC

Other: No intervention

Interventions

No interventionOTHER

Observational study, no intervention

Patients with (suspicion of) primary EOCPatients with recurrent EOC

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor material, ascites and blood samples before and/or during therapy.

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Judith R Kroep, MD PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith R Kroep, MD PhD

CONTACT

+31715263464j.r.kroep@lumc.nl

A F de Groot, MD

CONTACT

+31715299126a.f.de_groot@lumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator MD PhD

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 5, 2019

Study Start

August 15, 2020

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

NL(1)