Identifying immune markers in ovarian cancer patients
Determining Prognostic Immune Markers in Patients With Ovarian Cancer
This study is trying to find immune markers in women with ovarian cancer to see how they relate to treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Leiden University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Leiden) |
| Trial ID | NCT03862677 on ClinicalTrials.gov |
What this trial studies
The IMPRoVE study is a prospective, non-interventional cohort study aimed at identifying prognostic immune markers in patients diagnosed with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. It involves the collection of tumor material, ascites, and blood samples from patients undergoing surgery, chemotherapy, and/or immunotherapy. This observational approach allows researchers to monitor immune responses and their correlation with patient outcomes without administering any treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with primary or recurrent epithelial ovarian cancer who are scheduled for surgery, chemotherapy, or immunotherapy.
Not a fit: Patients with other active malignancies, severe infections, or those receiving immune suppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for better treatment decisions in ovarian cancer patients.
How similar studies have performed: Similar studies have shown promise in identifying immune markers in various cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leiden
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
Study contacts
- Principal investigator: Judith R Kroep, MD PhD — Leiden University Medical Center
- Study coordinator: Judith R Kroep, MD PhD
- Email: j.r.kroep@lumc.nl
- Phone: +31715263464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.