Collecting fluid from ovarian cancer patients to test new therapies
Single Institution (UNM) Prospective Laboratory Study of Cancer and Immune Cells in the Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies
This study is collecting fluid from women with ovarian cancer to see if it can help test new treatments that might work better for different types of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | New Mexico Cancer Research Alliance Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Trial ID | NCT03943316 on ClinicalTrials.gov |
What this trial studies
This study collects ascites fluid from women undergoing surgery for ovarian cancer to facilitate translational research. The fluid will be analyzed for cancer and immune cells, which will be used to test novel immunotherapies and develop patient-derived xenograft models. These models aim to better represent the heterogeneity of ovarian cancer, allowing for more effective preclinical testing of treatments. The research is conducted at the University of New Mexico Hospital or Cancer Center.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older who are undergoing cytoreductive surgery for suspected ovarian cancer.
Not a fit: Patients who do not have a confirmed diagnosis of ovarian cancer or are not undergoing surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more effective immunotherapies for ovarian cancer patients.
How similar studies have performed: While similar studies have explored the use of ascites fluid in cancer research, this specific approach to testing novel immunotherapies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All female participants, regardless of ethnicity, who are undergoing cytoreductive surgery for ovarian cancer are eligible for this study * All participants will be eighteen years old or older * Patients must be suspected of having a pathological diagnosis or clinical suspicion of ovarian cancer and be scheduled for surgery for tumor resection. * Ability to understand and the willingness to sign a written informed consent document. * Pathologic confirmation of a diagnosis of epithelial adenocarcinoma of the ovary, fallopian tube, or primary peritoneal cancer (serous, mucinous, clear cell, endometrioid, undifferentiated, mixed, transitional cell) * Women of childbearing potential must have a negative qualitative serum pregnancy test ≤ 2 weeks prior to study entry. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Exclusion Criteria: * We do not intend to include participants if they are unable to provide informed consent for this study themselves (e.g. mentally ill patients who require health care proxies to consent for any medical intervention), or vulnerable populations such as prisoners. * Minors under age eighteen. * Pregnant women. * Final pathologic diagnosis that does not confirm invasive epithelial ovarian, tubal, or primary peritoneal cancer
Where this trial is running
Albuquerque, New Mexico
- University of New Mexico Cancer Center — Albuquerque, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Adams, MD — UNM Comprehensive Cancer Center
- Study coordinator: Sarah Adams, MD
- Email: SAdams@salud.unm.edu
- Phone: (505) 925-0461
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.