Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers (NCT07696169) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers
1,000 participantsStarted 2026-07
Plain-language summary
This study aims to investigate the disease progression trends and risk factors of common AIDS-related tumors, including Kaposi sarcoma, lymphoma, lung cancer, and et al., among people living with HIV. By analyzing clinical data, the researchers hope to better understand how these cancers develop in HIV-infected patients and identify factors that may increase the risk. The findings may help improve early detection and treatment strategies for these cancers in the HIV population. This is an observational study, meaning participants will receive their usual medical care while researchers collect and analyze their health information. No experimental treatments will be given as part of this study.
Who can participate
Age range
18 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
. Age ≥ 18 years at the time of HIV diagnosis or study enrollment.
. Confirmed diagnosis of HIV-1 infection documented by positive serological testing (HIV antibody screening with confirmatory Western blot or HIV-1 RNA PCR).
. Confirmed HIV-1 infection based on established clinical and/or immunological criteria (e.g., CD4+ T-cell count \< 200 cells/μL, or presence of AIDS-defining conditions).
. For the cohort phase: Received continuous or intermittent care at one of the participating centers with available baseline clinical data (CD4 count, HIV viral load, ART history) and at least 6 months of follow-up data.
. For the nested case-control analysis - Cases: Pathologically or clinically diagnosed with an AIDS-related malignancy during the study period, specifically one of the following: Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer.
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
Cumulative incidence of AIDS-related malignancies
Timeframe: From the date of HIV diagnosis to the date of first documented AIDS-related malignancy diagnosis, the date of death from any cause, or the end of the study period, whichever occurs first, assessed up to 10 years (120 months).
2
Independent risk factors for AIDS-related malignancy development
Timeframe: From the date of HIV diagnosis to the date of first documented AIDS-related malignancy diagnosis, the date of death from any cause, or the date of last follow-up, whichever occurs first, assessed up to 10 years (120 months).
. For the nested case-control analysis - Controls: HIV-infected patients without a history of AIDS-related malignancy at the time of matching, selected from the same cohort using incidence density sampling.
. Able and willing to provide written informed consent for prospective data collection, medical record review, and follow-up (applicable to the prospective component).
Exclusion criteria
. Concurrent malignancy other than the study-specified AIDS-related malignancy (for cases); or presence of any AIDS-related malignancy (for controls).
. Systemic high-dose corticosteroid therapy (equivalent to prednisone ≥ 20 mg/day for ≥ 2 weeks) within 6 months prior to the index date.
. Severe comorbid systemic disease or major organ dysfunction (e.g., decompensated cirrhosis, New York Heart Association Class III-IV heart failure, severe chronic kidney disease with eGFR \< 30 mL/min) that would independently limit survival or preclude study participation.
. Inability or unwillingness to comply with study procedures, including clinical data collection, biological specimen collection, and follow-up assessments.
. Pregnancy at the time of enrollment (for the prospective component only).
. Any other condition that, in the judgment of the investigator, would compromise the subject's ability to participate in the study or interfere with the interpretation of study results.