Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers

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.

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Key information

Conditions

HIV (Human Immunodeficiency Virus) AIDS AIDS-Related Malignancy Acquired Immunodeficiency Syndrome Anal Cancer Anus Diseases Anus Neoplasms Blood-Borne Infections Cervical Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections Head and Neck Neoplasms Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Kaposi Sarcoma (KS) Lentivirus Infections Lung Cancer in the HIV Patient Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Oral Cancer RNA Virus Infections Rectal Diseases Rectal Neoplasms Retroviridae Infections Sarcoma Sarcoma, Kaposi Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stomatognathic Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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).

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.
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).

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.

Sponsors and collaborators

Lead sponsor

Shenzhen Third People's Hospital

Other

Collaborators

Beijing Ditan Hospital
Chongqing Public Health Medical Center
Fudan University
Guangzhou Eighth People's Hospital, Guangzhou Medical University.
Nanfang Hospital, Southern Medical University
Xinjiang Uygur Autonomous Region Infectious Disease Hospital

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jul 10, 2026
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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