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

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ClinicalTrials.gov Identifier: NCT03771651
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Fallopian Tube Infection Drug: Aspirin 81 mg Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Surgical Window Pilot Investigation of Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
Subjects will take 81mg tablets of aspirin daily for 14 days prior to surgery for removal of fallopian tubes.
Drug: Aspirin 81 mg
Subjects will take aspirin daily for 14 days leading up to surgery to determine whether it impacts inflammation of fallopian tubes.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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), acetominophen 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771651


Contacts
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Contact: Ingrid Block, APRN 405 271-8777 ingrid-block@ouhsc.edu

Locations
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United States, Oklahoma
Stephenson Cancer Center, University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Ingrid Block    405-271-8777    ingrid-block@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Doris Benbrook Stephenson Cancer Center, University of Oklahoma Health Sciences Center

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03771651     History of Changes
Other Study ID Numbers: 9955
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Aspirin
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics