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

• ClinicalTrials.gov Identifier: NCT05328765
• Recruitment Status: Recruiting
• First Posted: April 14, 2022
• Last Update Posted: June 22, 2023
• Sponsor: Latin American Cooperative Oncology Group
• Information provided by (Responsible Party): Latin American Cooperative Oncology Group

Tracking Information

• First Submitted Date: April 5, 2022
• First Posted Date: April 14, 2022
• Last Update Posted Date: June 22, 2023
• Actual Study Start Date: June 9, 2023
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2022)

• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   None Retained

Description:

We will also note whether tumor tissue is available from pre-treatment biopsy at the participating center to plan future translational studies.

• 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.

Condition

• Anal Squamous Cell Carcinoma
• HIV Infections

• Intervention: Not Provided

Study Groups/Cohorts

• With HIV Infection
  Patients with CCA with HIV infection,
• Without HIV Infection
  Patients with CCA without HIV infection,

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 13, 2022): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 HIV infection
• Any clinical stage

Exclusion Criteria:

• Lack of data on treatments and clinical outcomes

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Laura Mendonça Diefenthäeler; +55 51 3384 5334; laura.mendonca@lacogcancerresearch.org

Contact: Laura Voelcker; +55 51 3384 5334

• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT05328765
• Other Study ID Numbers: LACOG 0421
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Latin American Cooperative Oncology Group
• Original Responsible Party: Same as current
• Current Study Sponsor: Latin American Cooperative Oncology Group
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rachel Riechelmann; Brazilian Group of Gastrointestinal Tumors

• PRS Account: Latin American Cooperative Oncology Group
• Verification Date: June 2023