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出境医 / 临床实验 / Laboratory Study of Cancer & Immune Cells in Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies
Laboratory Study of Cancer & Immune Cells in Ascites Fluid of Ovarian Cancer Patients to Test Alternative Therapies
Study Description
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
| 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 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
| 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
Contacts
| Contact: Sarah Adams, MD | (505) 925-0461 | SAdams@salud.unm.edu | |
| Contact: Amy Overby | 505-272-5557 | Aoverby1@salud.unm.edu |
Locations
| 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
| Principal Investigator: | Sarah Adams, MD | UNM Comprehensive Cancer Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 7, 2019 | ||||||||
| First Posted Date | May 9, 2019 | ||||||||
| Last Update Posted Date | May 12, 2021 | ||||||||
| Actual Study Start Date | December 2, 2015 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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.
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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 | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Ascites fluid
|
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| 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. | ||||||||
| Condition | Ovarian Cancer | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
100 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03943316 | ||||||||
| Other Study ID Numbers | INST UNM 1509 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | New Mexico Cancer Care Alliance | ||||||||
| Study Sponsor | New Mexico Cancer Care Alliance | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | New Mexico Cancer Care Alliance | ||||||||
| Verification Date | May 2021 | ||||||||
