Determining Prognostic Immune Markers in Patients With Ovarian Cancer

NCT ID: NCT03862677

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-15

Study Completion Date

2027-01-31

Brief Summary

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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).

Detailed Description

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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

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Epithelial Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with (suspicion of) primary EOC

No intervention

Intervention Type OTHER

Observational study, no intervention

Patients with recurrent EOC

No intervention

Intervention Type OTHER

Observational study, no intervention

Interventions

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No intervention

Observational study, no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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J.R. Kroep

Principal Investigator MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith R Kroep, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Judith R Kroep, MD PhD

Role: CONTACT

+31715263464

A F de Groot, MD

Role: CONTACT

+31715299126

Facility Contacts

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Judith R Kroep, MD PhD

Role: primary

Other Identifiers

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NL66869.058.19

Identifier Type: -

Identifier Source: org_study_id

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