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Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America

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ClinicalTrials.gov Identifier: NCT04089488
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Brief Summary:
This trial studies the frequency of incident and prevalent of cancer in people living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) at cancer centers in Latin America. By counting how many people living with HIV/AIDS have cancer at these specific centers, researchers may better understand how they are being treated and cared for. This may help researchers to understand what new studies may be helpful for those areas in the future.

Condition or disease Intervention/treatment
HIV Infection Human Immunodeficiency Virus 1 Positive Malignant Neoplasm Recurrent Malignant Neoplasm Other: Medical Chart Review Other: Survey Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the number of diagnosed cancers in people living with HIV/AIDS (PLWHA) presenting to participating clinical sites in Latin America, and estimate site-specific prevalence based on all presenting cancers (new diagnosis, recurrence, and surveillance cases) and site-specific incidence based on newly diagnosed cancers.

SECONDARY OBJECTIVES:

I. Obtain information on the use of diagnostic testing and treatment for the cohort of diagnosed HIV-associated cancer participants.

II. To collect information on participant characteristics for diagnosed HIV-associated cancers (e.g., antiretroviral therapy [ART] regimen, current CD4 count, current viral load, etc.).

EXPLORATORY OBJECTIVES:

I. To determine the timelines and requirements for protocol review and approval at the local, regional, and national level.

II. To familiarize local sites with the online data entry systems utilized by the AIDS Malignancy Consortium (AMC).

OUTLINE:

Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Observational Study of Site-Specific Incident and Prevalent Cases of Cancer in People Living With HIV/AIDS- in Latin America
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Observational (respond to surveys, medical record review)
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.
Other: Medical Chart Review
Correlative studies
Other Name: Chart Review

Other: Survey Administration
Respond to surveys




Primary Outcome Measures :
  1. Estimates of site-specific incident cases and site-specific prevalence of cases presenting with human immunodeficiency virus (HIV) and cancer presenting over 9 months at the clinical sites [ Time Frame: Up to 9 months ]
    For each geographic site and type of cancer, the number of incident and prevalent cases will be estimated using a 95% Poisson confidence interval.


Secondary Outcome Measures :
  1. Information on the use of diagnostic testing and treatment for cancers diagnosed in HIV-positive individuals [ Time Frame: Up to 9 months ]
    The frequency of diagnostic testing modalities and cancer treatment regimens will be summarized for cancer.

  2. HIV treatment and disease characteristics of HIV-positive individuals diagnosed with cancer [ Time Frame: Up to 9 months ]
    For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics.


Other Outcome Measures:
  1. Timelines and requirements for protocol review and approval at the local, regional, and national level [ Time Frame: Up to 9 months ]
  2. Familiarization of local sites with the on-line data entry system utilized by the acquired immunodeficiency syndrome (AIDS) Malignancy Consortium (AMC) [ Time Frame: Up to 9 months ]


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.


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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
Participants presenting to HIV treatment programs or cancer treatment programs at collaborating sites, with both HIV and cancer, which may include either a history of malignancy or current diagnosis
Criteria

Inclusion Criteria:

  • HIV positive. Documentation of HIV-1 infection by means of any one of the following:

    • Documentation of receipt of ART by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name);
    • HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL, and confirmed by a licensed screening antibody and/or HIV antibody/antigen combination assay;
    • Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay, such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
    • Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally.
    • WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/Custom Industrial Analysis (CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
  • Must have a current or prior (within the last 5 years) diagnosis of cancer, but there is no restriction of the number or type of prior treatments. Participants will qualify under one of three categories:

    • New diagnosis: no prior treatment for current malignancy. May be prior to, or currently receiving the first line of therapy.
    • Prior diagnosis (within 5 years), in remission: Not currently on cancer treatment other than combination antiretroviral therapy (cART). Prior treatment for malignancy can include surgery, radiation, or chemotherapy (or cART initiation in Kaposi sarcoma [KS]). No restriction on number of prior lines of therapy.
    • Prior diagnosis, recurrent: considering or currently receiving treatment that is not first line. No restriction on the number of prior lines of therapy.
  • Date of birth and age should be determined based on best possible information or documentation available.
  • Ability to understand and the willingness to provide informed consent document.

Exclusion Criteria:

  • Participants not meeting all criteria above are ineligible.

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): NCT04089488


Locations
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Argentina
Fundación Huésped Not yet recruiting
Buenos Aires, Argentina
Contact: Pedro Cahn, MD PhD    (5411) 49817777    pedro.cahn@huesped.org.ar   
Brazil
Instituto Nacional de Câncer José de Alencar Not yet recruiting
Rio De Janeiro, Brazil, 20231-050
Contact: Fabio Leal, MD, PhD    552132076557    fabio.leal@inca.gov.br   
Complexo Hospitalar Universitário Professor Edgard Santos Not yet recruiting
Salvador, Brazil
Contact: Carlos Brites, MD PhD    557132838123    crbrites@ufba.br   
Mexico
Instituto Nacional de Cancerologia Not yet recruiting
Ciudad de Mexico, Mexico, 14080
Contact: Patricia Volkow, MD    525556280400 ext 12120    pvolkowf@gmail.com   
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert M Strother AIDS Malignancy Consortium

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Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT04089488     History of Changes
Other Study ID Numbers: AMC-S008
NCI-2019-01734 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AMC-S008 ( Other Identifier: AIDS Malignancy Consortium )
AMC-S008 ( Other Identifier: CTEP )
UM1CA121947 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Recurrence
Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes