Summary
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.
Key Facts
Lead Sponsor
Enrollment
Start Date
Completion Date
Study Type
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Conditions
Eligibility
Age Range
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Inclusion Criteria: 1. Presumed diagnosis of tumor of müllerian origin, specifically epithelial ovarian, fallopian tube, primary peritoneal, or uterine endometrial cancer. After biopsy portion of study, only patients with histologically or cytologically confirmed diagnosis of eligible malignancies will continue. 2. Be considered a candidate for neoadjuvant chemotherapy per institutional standards. 3. Be willing and able to provide written informed consent for the trial. 4. Be ≥ 18 years of age on day of signing informed consent. 5. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen upon agreement of the investigator. 6. Have a performance status of 0-2 on the ECOG Performance Scale. 7. Female subjects of childbearing potential should have a negative urine pregnancy test within 48 hours prior initial biopsy or administration of chemotherapy whichever comes first. Exclusion Criteria: 1. Is currently participating and receiving a study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device for this diagnosis. 2. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer. 3. Has a history or current evidence of any condition (i.e. infection), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 4. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 5. Is pregnant or breastfeeding.