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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    New Mexico Cancer Care Alliance
Updated on 22 October 2022
ascites
adenocarcinoma
fallopian tube
peritoneal cancer
primary peritoneal carcinoma
cytoreductive surgery
cancer of the ovary
surgery for ovarian cancer

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

Details
Condition Ovarian Cancer
Clinical Study IdentifierNCT03943316
SponsorNew Mexico Cancer Care Alliance
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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