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Active, Not Recruiting

NCT Number: NCT03771651

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Stephenson Cancer Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 5 years

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

  2. Number of subjects who exhibited less carcinogenic potential than control specimens

    Time frame: 5 years

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

A Surgical Window Pilot Investigation of Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube

Important dates

Study start
2019
Primary completion
2022
Study completion
2026
First posted
Dec 11, 2018
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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