This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05328765
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : June 22, 2023
Sponsor:
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Anal Squamous Cell Carcinoma HIV Infections

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : June 9, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
With HIV Infection
Patients with CCA with HIV infection,
Without HIV Infection
Patients with CCA without HIV infection,


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


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.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05328765


Contacts
Layout table for location contacts
Contact: Laura Mendonça Diefenthäeler +55 51 3384 5334 laura.mendonca@lacogcancerresearch.org
Contact: Laura Voelcker +55 51 3384 5334

Locations
Layout table for location information
Brazil
A.C. Camargo Cancer Center Recruiting
São Paulo, Brazil, 01509-001
Principal Investigator: Marcos Camandaroba         
Sponsors and Collaborators
Latin American Cooperative Oncology Group
Investigators
Layout table for investigator information
Principal Investigator: Rachel Riechelmann Brazilian Group of Gastrointestinal Tumors
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT05328765    
Other Study ID Numbers: LACOG 0421
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Latin American Cooperative Oncology Group:
HIV Infections
Anal Squamous Cell Carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Carcinoma
Carcinoma, Squamous Cell
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms, Squamous Cell
Blood-Borne 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
Slow Virus Diseases
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms