An observational study in Ovarian Cancer, Fallopian Tube Cancer and Peritoneal Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by Duke University · Observational
The investigators propose to collect biologic samples (i.e. tumor tissue, ascites, and/or blood), from patients undergoing standard of care therapy for a gynecologic malignancy. To detect changes in the immune response following chemotherapy, collection of biologic samples will occur at baseline and at the time of surgery following chemotherapy.
This is a single-institution, non-interventional prospective observational study allowing for specimen and data collection. All participants will receive standard of care surgery and chemotherapy, determined by the gynecologic oncologist and per institutional protocols. Patients with a presumed diagnosis of an eligible gynecologic malignancy (epithelial ovarian, fallopian tube, primary peritoneal, or uterine endometrial cancer) who are being considered for neoadjuvant chemotherapy prior to confirmatory biopsy will be given the option to enroll on this study.
Patients will undergo standard biopsy or endometrial curettage to confirm diagnosis. Additional tumor tissue for research purposes will be collected at the time of biopsy (if safely available). Patients who are undergoing diagnostic or therapeutic paracentesis will have the option to consent to allow excess ascites to be evaluated in this research protocol. Additionally, a research blood sample will be collected on the same day as the biopsy/curettage.
After confirmation of diagnosis, chemotherapy administration will proceed per standard institutional protocol and surgical planning will be performed by the treating gynecologic oncologist. Excess tumor tissue and ascites from the cytoreductive surgery will be collected for immune profiling. An additional vial of blood for research will be collected within 3 days prior to surgery. Post-surgical treatment and chemotherapy will proceed per standard procedures. After completion of post-surgical adjuvant therapy, an additional vial of blood for research will be collected (at next scheduled clinic visit).
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This study's enrollment of 47 is below the median of 179 across 321 observational studies indexed under Endometrial Neoplasms.
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Patients with a presumed diagnosis of an eligible gynecologic malignancy (epithelial ovarian, fallopian tube, primary peritoneal, or uterine endometrial cancer) who are being considered for neoadjuvant chemotherapy prior to confirmatory biopsy will be given the option to enroll on this study.
Exclusion Criteria:
Change in number and type of tumor infiltrating lymphocytes
To assess changes in the immune response through the characterization of tumor infiltrating lymphocytes (TILs) after administration of chemotherapy. Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.
Time frame: baseline, post treatment (approximately 6 months)
Change in expression level of Inflammatory mediators
To assess changes in immune response through the characterization of inflammatory mediators after administration of chemotherapy. Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.
Time frame: baseline, post treatment (approximately 6 months)
Change in tumor expression level of PD-L1
To assess changes in the immune response through the characterization of tumor expression of PD-L1 after administration of chemotherapy. Identify immune signatures/biomarkers that predict treatment outcomes. Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.
Time frame: baseline, post treatment (approximately 6 months)
Changes in HLA-type
To assess changes in HLA-type after administration of chemotherapy. Identify immune signatures/biomarkers that predict treatment outcomes. Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.
Time frame: baseline, post treatment (approximately 6 months)
Plan to share: Undecided
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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