Back to resultsShort Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube
Primary Purpose
Fallopian Tube Cancer, Fallopian Tube Infection
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aspirin 81 mg
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer
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
Sites / Locations
- Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aspirin
Arm Description
Subjects will take 81mg tablets of aspirin daily for 14 days prior to surgery for removal of fallopian tubes.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771651
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Fallopian Tube Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Subjects will take 81mg tablets of aspirin daily for 14 days prior to surgery for removal of fallopian tubes.
Intervention Type
Drug
Intervention Name(s)
Aspirin 81 mg
Intervention Description
Subjects will take aspirin daily for 14 days leading up to surgery to determine whether it impacts inflammation of fallopian tubes.
Primary Outcome Measure Information:
Title
Number of subjects who exhibited alterations in the fallopian tube immune microenvironment
Description
Immuno-cellular assays and percentages of specific immune cells will be compared to control tissue samples.
Time Frame
5 years
Title
Number of subjects who exhibited less carcinogenic potential than control specimens
Description
Ciliate cells from specimens will be isolated and the number of colony forming units will be compared to control samples.
Time Frame
5 years
Title
Number of subjects who exhibited changes in transcriptome profile compared to control specimens
Description
Normal fallopian tube fibria will be compared to ovarian cancer specimens to identify novel biomarkers for diagnosis, targets for prevention and better treatment strategies.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Holman
Organizational Affiliation
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube
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