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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943316
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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

Condition or disease
Ovarian Cancer

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
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : December 2, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Ascites fluid

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943316


Contacts
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Contact: Sarah Adams, MD (505) 925-0461 SAdams@salud.unm.edu
Contact: Amy Overby 505-272-5557 Aoverby1@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Amy Overby    505-272-5557    Aoverby1@salud.unm.edu   
Contact: Sharareh Sazesh, MS       ssazesh@salud.unm.edu   
Principal Investigator: Sarah Adams, MD         
Sub-Investigator: Carolyn Muller, MD         
Sub-Investigator: Bridget Wilson, PhD         
Sub-Investigator: Laurie Hudson, PhD         
Sub-Investigator: Angela Wandinger-Ness, PhD         
Sub-Investigator: Helen Hathaway, PhD         
Sub-Investigator: Eric Prossnitz, PhD         
Sub-Investigator: Mara Steinkamp, PhD         
Sub-Investigator: Sabrina Samudio-Ruiz, PhD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
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Principal Investigator: Sarah Adams, MD UNM Comprehensive Cancer Center
More Information
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Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT03943316    
Other Study ID Numbers: INST UNM 1509
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by New Mexico Cancer Care Alliance:
Ovarian Cancer
Ascites
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Ascites
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes