Laboratory Study of Cancer & Immune Cells in Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies

Ovarian Cancer Clinical Trial

Official title:

Single Institution (UNM) Prospective Laboratory Study of Cancer and Immune Cells in the Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03943316
• Other study ID #: INST UNM 1509
• Status: Recruiting
• Start date: December 2, 2015
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: New Mexico Cancer Care Alliance
• Contact: Sarah Adams, MD
• Phone: (505) 925-0461
• Email: SAdams[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ascites samples from women undergoing surgery for ovarian cancer will be collected for use in translational research.

Description:

The purpose of this study is to collect ascites fluid obtained from ovarian cancer patients during cytoreductive surgery or paracentesis at the University of New Mexico Hospital or Cancer Center. Cancer cells and immune cells from the ascites fluid will be used to test novel immunotherapies for ovarian cancer treatment and to establish patient derived xenograft models to perform preclinical testing on a cancer cell population that better models the heterogeneity in patient disease

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect ascites fluid obtained from ovarian cancer patients during cytoreductive surgery or paracentesis	To elucidate the conditions of the tumor environment that contribute to cancer dissemination in the peritoneal cavity through ex vivo evaluation of malignant ascites collected from women with ovarian, tubal, or primary peritoneal cancer.	5 years
Secondary	To correlate specific features of peritoneal cell populations or soluble factors with patient outcome.	To correlate specific features of peritoneal cell populations or soluble factors with patient outcome.	5 years