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Not yet recruitingNCT07696169Updated Jul 10, 2026

Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers

An observational study in HIV (Human Immunodeficiency Virus), AIDS and Kaposi Sarcoma (KS), sponsored by Shenzhen Third People's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Shenzhen Third People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • HIV (Human Immunodeficiency Virus)
  • AIDS
  • Kaposi Sarcoma (KS)
  • Lymphoma
  • AIDS-Related Malignancy
  • Lung Cancer in the HIV Patient
  • Cervical Cancer
  • Anal Cancer
  • Oral Cancer
  • Colorectal Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will enroll approximately 1 000 HIV-infected adults aged 18 years and older from 7 infectious disease treatment centers across China. Participants include individuals with confirmed AIDS who are receiving routine clinical care. The study employs an ambidirectional (retrospective-prospective) cohort design with a nested case-control analysis. The cohort comprises HIV-infected patients with and without AIDS-related malignancies (including Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer). Within this cohort, cases are patients who developed malignancies during follow-up, and controls are matched HIV-infected patients without malignancies. The study population is intended to represent the broader demographic of adults living with HIV/AIDS under care in tertiary infectious disease centers in China.

Inclusion criteria

  1. Age ≥ 18 years at the time of HIV diagnosis or study enrollment.
  2. Confirmed diagnosis of HIV-1 infection documented by positive serological testing (HIV antibody screening with confirmatory Western blot or HIV-1 RNA PCR).
  3. 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).
  4. 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.
  5. 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.
  6. 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.
  7. 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

Exclusion Criteria:

  1. Concurrent malignancy other than the study-specified AIDS-related malignancy (for cases); or presence of any AIDS-related malignancy (for controls).
  2. Systemic high-dose corticosteroid therapy (equivalent to prednisone ≥ 20 mg/day for ≥ 2 weeks) within 6 months prior to the index date.
  3. 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.
  4. Inability or unwillingness to comply with study procedures, including clinical data collection, biological specimen collection, and follow-up assessments.
  5. Pregnancy at the time of enrollment (for the prospective component only).
  6. 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.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Ambidirectional cohort of people living with HIV

    A retrospective-prospective (ambidirectional) cohort of HIV-infected patients receiving care. The retrospective component analyzes historical clinical data to describe disease progression trends of AIDS-related malignancies (Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer). The prospective component continues enrollment and follow-up of people living with HIV to capture new malignancy occurrences. Within this unified cohort, a nested case-control analysis will be conducted: cases are patients who develop AIDS-related malignancies, and controls are matched people living with HIV without malignancies selected from the same cohort.

05

What researchers measure

Primary outcomes

  1. Cumulative incidence of AIDS-related malignancies

    The proportion of HIV-infected patients who develop AIDS-related malignancies (Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer) during the study period, calculated using Kaplan-Meier or competing risk methods.

    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).

  2. Independent risk factors for AIDS-related malignancy development

    Odds ratios (ORs) and hazard ratios (HRs) of potential risk factors (baseline CD4 count, nadir CD4, HPV infection, ART duration, age, smoking history) for malignancy occurrence, derived from multivariable logistic regression and Cox proportional hazards models.

    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).

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07696169
Lead sponsor
Shenzhen Third People's Hospital
Collaborators
Chongqing Public Health Medical Center, Xinjiang Uygur Autonomous Region Infectious Disease Hospital, Beijing Ditan Hospital, Fudan University, Guangzhou Eighth People's Hospital, Guangzhou Medical University., Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Jul 10, 2026
Start date
Jul 2026 (estimated)
Primary completion
Feb 2029 (estimated)
Completion
Feb 2029 (estimated)
Last update
Jul 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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