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

NCT03943316 | Recruiting

• 1 other identifier: INST UNM 1509
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Ascites

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To correlate specific features of peritoneal cell populations or soluble factors with patient outcome.

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Ascites fluid

MeSH Terms

Conditions

Ovarian Neoplasms; Ascites

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Adams, MD

  UNM Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Adams, MD

CONTACT

(505) 925-0461; SAdams@salud.unm.edu

Amy Overby

CONTACT

505-272-5557; Aoverby1@salud.unm.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: December 2, 2015
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)