Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue (NCT06132386) | Clinical Trial Compass
CompletedNot Applicable
Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue
United States21 participantsStarted 2023-08-07
Plain-language summary
The goal of this clinical study is to learn about the effect of aging on certain enzymes, or proteins, in the blood and colon. The study involves collection of blood and colon tissue biopsies using a flexible sigmoidoscope or colonoscope. This study is also investigating how medications tenofovir and emtricitabine interact with certain enzymes. The investigators will compare the difference in enzyme activity between people taking tenofovir and emtricitabine, to those who are not taking tenofovir and emtricitabine.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. English speaking male or female volunteers between the ages of 18-50 for younger adults or 65-80 for older adults
. Willing to provide written informed consent
. Willing to abstain from insertion of anything in rectum for 72 hours before and 72 hours after the endoscopic procedure for colorectal tissue collection.
. Not currently participating in other research studies involving drugs and/or medical devices.
. No known risk for HIV exposure or a documented negative HIV-1/HIV-2 Ag/Ab test in the past 3 months (HIV risk, but not on PrEP)
. Documented negative HBsAg in those taking study TFV (i.e. cohort B)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of AK2 in Colorectal Tissue
Timeframe: Once within one month
2
Concentration of CKM in Colorectal Tissue
Timeframe: Once within one month
3
Concentration of AK2 in Peripheral Blood Mononuclear Cells
. Currently taking TFV-based oral PrEP daily or willing to take oral TFV-containing PrEP for one week
. Documented negative HIV-1/HIV-2 Ag/Ab test in the past 3 months
Exclusion criteria
. History of inflammatory bowel disease or active inflammatory condition of the GI tract
. History of significant gastrointestinal bleeding
. Current medically-indicated use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[\>81 mg\], non-steroidal anti-inflammatory drugs \[NSAIDs\], or Pradaxa®)
. Use of systemic immunomodulatory medications within 4 weeks of enrollment
. Use of rectally administered medications within 4 weeks of enrollment
. Use of product containing nonoxynol-9 within 4 weeks of enrollment
. Use of any investigational products within 4 weeks of enrollment
. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease.