Clinical trial NCT03943316: Laboratory Study of Cancer & Immune Cells in Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Ascites
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Collect ascites fluid obtained from ovarian cancer patients during cytoreductive surgery or paracentesis
timeFrame: 5 years
Secondary outcomes:
measure: To correlate specific features of peritoneal cell populations or soluble factors with patient outcome.
timeFrame: 5 years
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: UNM Comprehensive Cancer Center
name: Sarah Adams, MD
role: PRINCIPAL_INVESTIGATOR
References: