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Recruiting

NCT Number: NCT03943316

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location status: Recruiting

Location contact

Amy Overby

CONTACT

[email protected]

505-272-5557

Angela Wandinger-Ness, PhD

SUB_INVESTIGATOR

Bridget Wilson, PhD

SUB_INVESTIGATOR

Carolyn Muller, MD

SUB_INVESTIGATOR

Eric Prossnitz, PhD

SUB_INVESTIGATOR

Helen Hathaway, PhD

SUB_INVESTIGATOR

Laurie Hudson, PhD

SUB_INVESTIGATOR

Mara Steinkamp, PhD

SUB_INVESTIGATOR

Sabrina Samudio-Ruiz, PhD

SUB_INVESTIGATOR

Sarah Adams, MD

PRINCIPAL_INVESTIGATOR

Sharareh Sazesh, MS

CONTACT

[email protected]

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Collect ascites fluid obtained from ovarian cancer patients during cytoreductive surgery or paracentesis

    Time frame: 5 years

    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.

Secondary outcomes

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

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Overby

CONTACT

[email protected]

505-272-5557

Sarah Adams, MD

CONTACT

[email protected]

(505) 925-0461

Sponsors and collaborators

Lead sponsor

New Mexico Cancer Research Alliance

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2027
First posted
May 9, 2019
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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