Recruiting NCT03862677
Determining Prognostic Immune Markers in Patients With Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Epithelial Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Other No intervention
Observational study, no intervention
Primary outcome measures
- 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 outcome measures (12)
- Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS [Time frame: 5 years]
- Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS [Time frame: 5 years]
- Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS [Time frame: 5 years]
- Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS [Time frame: 5 years]
- Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS [Time frame: 5 years]
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS [Time frame: 5 years]
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS [Time frame: 5 years]
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS [Time frame: 5 years]
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS [Time frame: 5 years]
- Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS [Time frame: 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 [Time frame: 5 years]
- Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Leiden University Medical Center — Leiden
Identifiers
NCT: NCT03862677 · NL66869.058.19