Laboratory Study of Cancer & Immune Cells in 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

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Updated on 7 February 2022

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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 Identifier	NCT03943316
Sponsor	New Mexico Cancer Care Alliance
Last Modified on	7 February 2022

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