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

L

Leiden University Medical Center (LUMC)

Status

Enrolling

Conditions

Epithelial Ovarian Cancer

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03862677
NL66869.058.19

Details and patient eligibility

About

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).

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Patients with (suspicion of) primary EOC
Treatment:
Other: No intervention
Patients with recurrent EOC
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Judith R Kroep, MD PhD; A F de Groot, MD

Data sourced from clinicaltrials.gov

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