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Determining Prognostic Immune Markers in Patients With Ovarian Cancer

ConditionEpithelial Ovarian Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorLeiden University Medical Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

The study will be carried out in patients with primary and recurrent EOC considered eligible for treatment with surgery, chemotherapy and/or immunotherapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    Observational study, no intervention

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Patients with (suspicion of) primary EOC1 intervention
Group B: Patients with recurrent EOC1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leiden University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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