ClinicalTrials.gg
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
01

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

In context

Acquired Immunodeficiency Syndrome

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Shenzhen Third People's Hospital is the lead sponsor of 10 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years at the time of 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., \< 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 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 for prospective data collection, medical record review, and follow-up (applicable to the prospective component).

Exclusion criteria

Exclusion Criteria:

  1. Concurrent other than the study-specified AIDS-related malignancy (for cases); or presence of any AIDS-related malignancy (for controls).
  2. Systemic high-dose 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, Class III-IV heart failure, severe chronic kidney disease with \< 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

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.

06

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).

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Feb 2029, 31 months later.

Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 31 months is below that.

Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2026
First posted
Jul 10, 2026
StartEst.
Jul 2026
Primary completionEst.
Feb 2029
CompletionEst.
Feb 2029
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion