Pilot Study of Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube
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|ClinicalTrials.gov Identifier: NCT03771651|
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Fallopian Tube Infection||Drug: Aspirin 81 mg||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Surgical Window Pilot Investigation of Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2023|
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.
- 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.
- 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.
- 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.
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
|Contact: Ingrid Block, APRN||405 firstname.lastname@example.org|
|United States, Oklahoma|
|Stephenson Cancer Center, University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73117|
|Principal Investigator:||Doris Benbrook||Stephenson Cancer Center, University of Oklahoma Health Sciences Center|