Characterizing the immune landscape in newly diagnosed epithelial ovarian cancer
The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study
This study is looking to understand the immune system's response in women newly diagnosed with different types of ovarian cancer by collecting samples from those starting surgery or chemotherapy, and comparing them to women having surgery for non-cancer issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Oncology Institute of Southern Switzerland Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bellinzona) |
| Trial ID | NCT05984875 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the immune landscape of newly diagnosed epithelial ovarian cancer by enrolling patients in four distinct cohorts based on their treatment plans. Patients will either undergo primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery, with a focus on both common and rare subtypes of the cancer. Additionally, a cohort of women undergoing adnexectomy for benign conditions will be included for comparative analysis. Biological samples, including tumor samples and blood, will be collected at specified time points to facilitate the study's objectives.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with a confirmed diagnosis of epithelial ovarian cancer planning to undergo surgical management.
Not a fit: Patients with other active cancers, autoimmune diseases requiring treatment, or those on chronic immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the immune response in ovarian cancer, potentially leading to improved treatment strategies.
How similar studies have performed: While the specific approach of characterizing the immune landscape in this context may be novel, similar studies have shown promise in understanding cancer immunology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria cohort A-D: * Suspicious diagnosis of epithelial ovarian cancer (subsequent histologically confirmation required) * Plan to undergo a surgical procedure for the management of epithelial ovarian cancer or recurrent ovarian cancer previously treated with conventional treatment and involved in the trial as group A-D * ≥18 years old * ECOG Performance Status ≤ 2 * Written informed consent Inclusion criteria cohort E: * Indication for adnexectomy for a benign gynecological condition * ≥18 years old * ECOG Performance Status ≤ 2 * Written informed consent Exclusion criteria cohort A-E: * Other active concomitant neoplasms that might confound the results of the planned analysis. * Ongoing active autoimmune disease requiring treatment or condition of immune deficiency * Ongoing chronic treatment with steroids or other immune suppressive agents at the time of study entry
Where this trial is running
Bellinzona
- Oncology Institute of Southern Switzerland — Bellinzona, Switzerland (Recruiting)
Study contacts
- Study coordinator: Ilaria Colombo, MD
- Email: ilaria.colombo@eoc.ch
- Phone: +41764528823
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.