ClinicalTrials.gg
CompletedNCT05328765ACTION HIVUpdated Aug 28, 2026

A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection

An observational study in Anal Squamous Cell Carcinoma and HIV Infections, sponsored by Latin American Cooperative Oncology Group. Completed at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Latin American Cooperative Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
369
Ages
18 Years and older
Sex
All
01

Study summary

Due to the scarcity of data on prognostic and predictive influence on CCA, epidemiological studies evaluating these factors need to be developed in patients with CCA. Therefore, the investigators want to evaluate the profile of patients in the real world and from various parts of the world, describing prognostic factors such as CD4 dosage, time of HIV infection, evaluation of viral load, diagnosis of AIDS, geographic region of diagnosis and treatment, clinical staging, medications concomitant with QRT (risk of drug interactions), comorbidities (possible impact on dose-intensity), use of HAART, time of use of HAART, radiotherapy modality (conventional 3D vs Modulated Beam Intensity [IMRT], response to Nigro vs CTII regimens, as well as comparing clinical outcomes with patients without HIV infection.

02

Conditions studied

  • Anal Squamous Cell Carcinoma
  • HIV Infections

Keywords

  • HIV Infections
  • Anal Squamous Cell Carcinoma
03

In context

Anus Neoplasms

297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.

This study's enrollment of 369 is above the median of 144 across 75 observational studies indexed under Anus Neoplasms.

Browse Anus Neoplasms studies →

Lead sponsor

Latin American Cooperative Oncology Group is the lead sponsor of 48 studies on the registry; 10 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

Potentially eligible patients will be screened through the administrative lists of participating centres. Based on convenience and viability, we estimate to accumulate 300 patients with CCA with and without HIV infection.

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

  • Patients 18 years of age or older
  • Confirmed histological diagnosis of anal canal squamous cell carcinoma. Basaloid subtype is accepted
  • Have underundered serological test for infection
  • Any clinical stage

Exclusion criteria

Exclusion Criteria:

  • Lack of data on treatments and clinical outcomes
Terms in these criteria, in plain language(1)

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.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
369 participants (actual)
Patient registry
No

Groups and cohorts

  • With HIV Infection

    Patients with CCA with HIV infection,

  • Without HIV Infection

    Patients with CCA without HIV infection,

06

What researchers measure

Primary outcomes

  1. Median disease-free survival

    Defined as time from Day 1 from initiation of treatment (or definition of exclusive supportive care) to tumor death or recurrence. Disease-free survival at 3 years after initiation of treatment: proportion of patients free of local or metastatic disease at 3 years after treatment termination according to imaging tests (chest, abdomen and pelvis scans) and clinical examination of anal inspection

    Time frame: 3 years

  2. Complete clinical response

    Absence of neoplasia on magnetic resonance imaging (preferred) or computed tomography of the pelvis and on clinical examination of anal inspection 6 months after the end of QRT or RT isolated

    Time frame: 6 months

  3. Overall survival

    Defined as the date from the D1 of treatment (or exclusive supportive care) to death from any cause; living patients at the time of the analysis will be censored.

    Time frame: From first date of treatment to date of death from any cause, assessed up to 3 years.

07

Study locations

11 sites
  • Hospital de Gastroenterología Carlos Bonorino Udaondo
    Buenos Aires, Buenos Aires, Argentina
  • INCA - Instituto Nacional de Câncer
    Rio de Janeiro, Rio de Janeiro 20230-130, Brazil
  • HUOL - Hospital Universitário Onofre Lopes da UFRN
    Natal, Rio Grande do Norte 59012-300, Brazil
  • Liga Norte Riograndense Contra o Câncer
    Natal, Rio Grande do Norte 59062-000, Brazil
  • CEPON - Centro de Pesquisas Oncológicas
    Florianópolis, Santa Catarina 88034-000, Brazil
  • Hospital de Amor de Barretos
    Barretos, São Paulo 14784-400, Brazil
  • A.C. Camargo Cancer Center
    São Paulo, São Paulo 01509-001, Brazil
  • INCan - Instituto Nacional de Cancerología
    Mexico City, Mexico City, Mexico
  • INEN - Instituto Nacional de Enfermedades Neoplásicas
    Lima, Peru, Peru
  • Oncosalud AUNA
    Lima, Peru, Peru
  • Hospital de Clínicas de Montevideo Dr. Manuel Quintela
    Montevideo, Uruguai, Uruguay
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Feb 2025, 19 months.

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

Registered
Apr 5, 2022
First posted
Apr 14, 2022
StartActual
Jun 9, 2023
Primary completionActual
Feb 7, 2025
CompletionActual
Feb 7, 2025
Last update
Aug 28, 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 Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05328765
Lead sponsor
Latin American Cooperative Oncology Group
Responsible party
Sponsor
First posted
Apr 14, 2022
Start date
Jun 9, 2023
Primary completion
Feb 7, 2025
Completion
Feb 7, 2025
Last update
Aug 28, 2026

Study contacts

Rachel Riechelmann
principal investigator · Brazilian Group of Gastrointestinal Tumors

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 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