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Not yet recruiting NCT07696169

Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers

— Observational HIV (Human Immunodeficiency Virus) AIDS Kaposi Sarcoma (KS) Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: HIV (Human Immunodeficiency Virus), AIDS, Kaposi Sarcoma (KS), Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Analysis of Disease Evolution Trends and Risk Factors of AIDS-related High-incidence Tumors

Overview

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.

Primary outcome measures

  • Cumulative incidence of AIDS-related malignancies [Time frame: 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).]
  • Independent risk factors for AIDS-related malignancy development [Time frame: 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).]

Eligibility criteria

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07696169 · No. [2026-043-01]

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗