Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers

NCT07696169 | Not Yet Recruiting

• 1 other identifier: No. [2026-043-01]
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

  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).

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sarcoma, Kaposi; Lymphoma; Uterine Cervical Neoplasms; Anus Neoplasms; Mouth Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Rectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-07