Clinical trial NCT03771651: Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube
Official title: A Surgical Window Pilot Investigation of Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Fallopian Tube Cancer
Fallopian Tube Infection
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects who exhibited alterations in the fallopian tube immune microenvironment
timeFrame: 5 years
measure: Number of subjects who exhibited less carcinogenic potential than control specimens
timeFrame: 5 years
measure: Number of subjects who exhibited changes in transcriptome profile compared to control specimens
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center, University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Stephenson Cancer Center, University of Oklahoma Health Sciences Center
name: Laura Holman
role: PRINCIPAL_INVESTIGATOR
References: