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

NCT03771651 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 9955
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Fallopian Tube Infection; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (3)

• Number of subjects who exhibited alterations in the fallopian tube immune microenvironment

  Immuno-cellular assays and percentages of specific immune cells will be compared to control tissue samples.

  5 years

• Number of subjects who exhibited less carcinogenic potential than control specimens

  Ciliate cells from specimens will be isolated and the number of colony forming units will be compared to control samples.

  5 years

• Number of subjects who exhibited changes in transcriptome profile compared to control specimens

  Normal fallopian tube fibria will be compared to ovarian cancer specimens to identify novel biomarkers for diagnosis, targets for prevention and better treatment strategies.

  5 years

Study Arms (1)

Aspirin

EXPERIMENTAL

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

Drug: Aspirin 81 mg

Interventions

Aspirin 81 mg DRUG

Subjects will take aspirin daily for 14 days leading up to surgery to determine whether it impacts inflammation of fallopian tubes.

Aspirin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Laura Holman

  Stephenson Cancer Center, University of Oklahoma Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: March 1, 2019
• Primary Completion: May 6, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)