Anal Squamous Cell CarcinomaACTION HIVNCT05328765
A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection
An observational study of Anal Squamous Cell Carcinoma and HIV Infections, run by Latin American Cooperative Oncology Group at 11 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Squamous Cell Carcinoma, HIV Infections
- How many people
- 369 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 9 Jun 2023to 7 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 HIV infection
- Any clinical stage
Who cannot join
- Lack of data on treatments and clinical outcomes
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Brazil6 sites
Hospital de Amor de Barretos
Barretos, São Paulo, 14784-400
CEPON - Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, 88034-000
HUOL - Hospital Universitário Onofre Lopes da UFRN
Natal, Rio Grande do Norte, 59012-300
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, 20230-130
A.C. Camargo Cancer Center
São Paulo, São Paulo, 01509-001
Peru2 sites
INEN - Instituto Nacional de Enfermedades Neoplásicas
Lima, Peru
Oncosalud AUNA
Lima, Peru
Argentina1 site
Hospital de Gastroenterología Carlos Bonorino Udaondo
Buenos Aires, Buenos Aires
Mexico1 site
INCan - Instituto Nacional de Cancerología
Mexico City, Mexico City
Uruguay1 site
Hospital de Clínicas de Montevideo Dr. Manuel Quintela
Montevideo, Uruguai
About this study
Official title: ACTION HIV (Anal Cancer TherapIes and Outcomes iNitiative for Patients Living With and Without HIV): A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection
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.
- Conditions
- Anal Squamous Cell Carcinoma, HIV Infections
- Keywords
- HIV Infections, Anal Squamous Cell Carcinoma
- Medical subject headings
- Anus Neoplasms, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With HIV Infection | Patients with CCA with HIV infection, | |
| Without HIV Infection | Patients with CCA without HIV infection, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
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
Measured: 6 months
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.
Measured: From first date of treatment to date of death from any cause, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start9 Jun 2023
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Riechelmann, Principal investigator, Brazilian Group of Gastrointestinal Tumors
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328765
- Sponsor's protocol ID
- LACOG 0421
- Acronym
- ACTION HIV
- Status last verified
- Aug 2026
- First submitted
- 5 Apr 2022
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTION HIV (Anal Cancer TherapIes and Outcomes iNitiative for Patients Living With and Without HIV): A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection
- ClinicalTrials.gov ID
- NCT05328765
- Acronym / sponsor ID
- ACTION HIV / LACOG 0421
- Conditions
- Anal Squamous Cell Carcinoma, HIV Infections
- Keywords
- HIV Infections, Anal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With HIV Infection | – | –Patients with CCA with HIV infection, |
| Without HIV Infection | – | –Patients with CCA without HIV infection, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 HIV infection
- Any clinical stage
Key exclusion criteria (1 listed)
- Lack of data on treatments and clinical outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median disease-free survival
Time frame: 3 years
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
Complete clinical response
Time frame: 6 months
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
Overall survival
Time frame: From first date of treatment to date of death from any cause, assessed up to 3 years.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Riechelmann principal investigator
Brazilian Group of Gastrointestinal Tumors
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Squamous Cell Carcinoma and HIV Infections, run by Latin American Cooperative Oncology Group at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil, Peru, Argentina, Mexico, Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median disease-free survival (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.