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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

Tracking Information
First Submitted Date September 12, 2019
First Posted Date September 13, 2019
Last Update Posted Date September 19, 2019
Estimated Study Start Date October 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04089488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 12, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2019)
  • Timelines and requirements for protocol review and approval at the local, regional, and national level [ Time Frame: Up to 9 months ]
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America
Official Title Prospective Observational Study of Site-Specific Incident and Prevalent Cases of Cancer in People Living With HIV/AIDS- in Latin America
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • HIV Infection
  • Human Immunodeficiency Virus 1 Positive
  • Malignant Neoplasm
  • Recurrent Malignant Neoplasm
Intervention
  • Other: Medical Chart Review
    Correlative studies
    Other Name: Chart Review
  • Other: Survey Administration
    Respond to surveys
Study Groups/Cohorts Observational (respond to surveys, medical record review)
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.
Interventions:
  • Other: Medical Chart Review
  • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 12, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Argentina,   Brazil,   Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT04089488
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 )
Has Data Monitoring Committee No
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
Plan to Share IPD: Undecided
Responsible Party AIDS Malignancy Consortium
Study Sponsor AIDS Malignancy Consortium
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert M Strother AIDS Malignancy Consortium
PRS Account AIDS Malignancy Consortium
Verification Date September 2019