This early phase I trial studies how well low-dose aspirin works in decreasing inflammation in patients undergoing gynecologic surgery that includes removal of their fallopian tube. Fallopian tube is a slender tube through which eggs pass from an ovary to the uterus. Low-dose aspirin may decrease inflammation in the fallopian tubes and may provide new information on ovarian cancer prevention that could benefit other patients in the future.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03771651.
PRIMARY OBJECTIVES:
I. Compare immuno-molecular assays and percentages of specific immune cell types; such as M1 and M2 macrophages and tissue and serum cytokine expression such as IL-6, IL-10 and TGF-beta in the aspirin treated fallopian tubes and blood compared to control tissue samples.
II. Compare the number of colony forming units in cultures of fallopian tube secretory epithelial cells and fallopian tube ciliated cells treated with a carcinogen in the aspirin and control group fallopian tube specimens.
III. To study the CCL2 gene single nucleotide polymorphism (SNP) in normal fallopian tube fimbria by comparing the percentages of specific immune cell types in fallopian tubes from women treated with aspirin with the AA, AT and TT rs1860190 genotypes with each other and with the immune cell profiles determined for ovarian cancer specimens that are being determined for ovarian cancer specimens in a separate Institutional Review Board (IRB) protocol.
OUTLINE:
Patients receive low-dose aspirin orally (PO) daily for 14 days in the absence of disease progression or unacceptable toxicity, prior to their scheduled fallopian tube surgery.
Lead OrganizationUniversity of Oklahoma Health Sciences Center
Principal InvestigatorLaura L. Holman