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

NCT05328765 | Recruiting

• 1 other identifier: LACOG 0421
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Squamous Cell Carcinoma; HIV Infections

Keywords

HIV Infections; Anal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

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

Study Arms (2)

With HIV Infection

Patients with CCA with HIV infection,

Without HIV Infection

Patients with CCA without HIV infection,

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

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.

You may qualify if:

• 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

You may not qualify if:

• Lack of data on treatments and clinical outcomes

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead

Study Sites (1)

A.C. Camargo Cancer Center

São Paulo, 01509-001, Brazil

RECRUITING

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Conditions

Anus Neoplasms; HIV Infections

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Rachel Riechelmann

  Brazilian Group of Gastrointestinal Tumors

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviane Horn de Melo

CONTACT

+55 51 3384 5334; viviane.melo@lacogcancerresearch.org

Laura Voelcker

CONTACT

+55 51 3384 5334; laura.voelcker@lacogcancerresearch.org

Study Design

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

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 14, 2022
• Study Start: June 9, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: March 7, 2025

Record last verified: 2024-07

Locations

BR (1)