Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube

Early Phase 1

Active, not recruiting

• Conditions: Fallopian Tube Cancer; Fallopian Tube Infection
• Interventions: Drug: Aspirin 81 mg

• Registration Number: NCT03771651
• Lead Sponsor: University of Oklahoma

Brief Summary

This study will evaluate the impact of low dose aspirin on normal fallopian tube fimbriae in women who have surgery to have their fallopian tubes removed. Participants will take a low dose of aspirin for 2 weeks before their surgery. A portion of the removed fallopian tubes will also be collected for future research and routine pathology purposes.

Detailed Description

Subjects in this study will receive low dose aspirin for 14 days before undergoing surgery to remove fallopian tubes removed to determine whether aspirin decreases inflammation in the fallopian tube. Subjects will also submit blood samples at their initial visit with their oncologist, at the time of surgery and at the pre-operative visit to measure inflammation markers and blood counts. A portion of the subject's fallopian tube will be collected for future research studies.

Study Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-11
• Study Start: 2019-03-01
• Primary Completion: 2022-05-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• Women undergoing gynecologic surgery for presumed benign indications that includes the removal of their fallopian tubes. This may include sterilization procedures, hysterectomy or partial or full adnexectomy.
• Eligible women will have fulfilled their childbearing desires
• Age > 21 Considered low risk for prevalent fallopian tube cancer (not undergoing risk reducing surgery for a known BRCA mutation or other known hereditary predisposition syndrome, family history of ovarian cancer in a first degree relative.

Exclusion Criteria

• Males
• Women who have presumed or known gynecologic cancer
• Women less than 21 years of age
• Women currently on either regular aspirin therapy, non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen or chronic steroidal anti-inflammatory medications.
• Women with known bleeding diathesis or bleeding disorder.
• Women who do not consent for removal of both fallopian tubes.
• Women with a history of gastritis or peptic ulcer disease requiring treatment. (Patients with a history of occasional H1 or H2 blocker use for gastro esophageal reflux disease are NOT excluded).
• Women with reported aspirin or NSAID allergy
• Women with asthma and/or nasal polyps

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin 81 mg	Subjects will take 81mg tablets of aspirin daily for 14 days prior to surgery for removal of fallopian tubes.

Primary Outcome Measures

Name	Time	Method
Number of subjects who exhibited less carcinogenic potential than control specimens	5 years	Ciliate cells from specimens will be isolated and the number of colony forming units will be compared to control samples.
Number of subjects who exhibited alterations in the fallopian tube immune microenvironment	5 years	Immuno-cellular assays and percentages of specific immune cells will be compared to control tissue samples.
Number of subjects who exhibited changes in transcriptome profile compared to control specimens	5 years	Normal fallopian tube fibria will be compared to ovarian cancer specimens to identify novel biomarkers for diagnosis, targets for prevention and better treatment strategies.

Trial Locations

Locations (1)

Stephenson Cancer Center, University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States