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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Emmes Company, LLC | INDUSTRY |
| University of Arkansas | OTHER |
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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.
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.).
OUTLINE:
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (respond to surveys, medical record review) | Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Chart Review | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The primary endpoint will be the estimates of site-specific frequency of new diagnosis and existing cases (recurrence and surveillance) presenting with HIV and cancer presenting over 1 year, 9 months (21 months) at the clinical sites. | Up to 21 months |
| Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site. | The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the study site. | 21 months |
| Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type. | The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the cancer type. | 21 months |
| Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site. | The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the study site. | 21 months |
| Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type |
| Measure | Description | Time Frame |
|---|---|---|
| Information on the Use of Diagnostic Testing in HIV-positive Individuals | The frequency of diagnostic testing modalities will be summarized for cancer. | Up to 21 months |
| HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer |
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Inclusion Criteria:
HIV positive. Documentation of HIV-1 infection by means of any one of the following:
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:
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:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Strother | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Agudos Juan A. Fernandez | Buenos Aires | Argentina | ||||
| Instituto Nacional de Câncer José de Alencar |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational (Respond to Surveys, Medical Record Review) | Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2021 |
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| Survey Administration | Other | Respond to surveys |
|
The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the cancer type. |
| 21 months |
For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics. |
| Up to 21 months |
| Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals | The frequency of the Treatment for Cancers Diagnosed in HIV-positive Individuals will be summarized. | Up to 21 months |
| CD4 of HIV-positive Individuals Diagnosed With Cancer | CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized. | Baseline |
| HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer | HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized | Baseline |
| Rio de Janeiro |
| 20231-050 |
| Brazil |
| Complexo Hospitalar Universitário Professor Edgard Santos | Salvador | Brazil |
| Instituto Nacional de Cancerologia | Mexico City | 14080 | Mexico |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational (Respond to Surveys, Medical Record Review) | Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The primary endpoint will be the estimates of site-specific frequency of new diagnosis and existing cases (recurrence and surveillance) presenting with HIV and cancer presenting over 1 year, 9 months (21 months) at the clinical sites. | There are five study sites (Complexo Hospitalar; Hospital Fernandez; Hospital Roff0; Instituto Nacional De Cancer Brazil ; and Instituto de Oncologia). Given a study site, new diagnosis and existing cases(recurrence and surveillance) are summarized. | Posted | Count of Participants | Participants | Up to 21 months |
|
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| ||||||||||||||||||||||||||||||
| Primary | Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site. | The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the study site. | There are five study sites (Complexo Hospitalar; Hospital Fernandez; Hospital Roff0; Instituto Nacional De Cancer Brazil ; and Instituto de Oncologia). Given a study site, new diagnosis cases are summarized using cases per month. | Posted | Mean | 95% Confidence Interval | New diagnosis cases per month | 21 months |
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| ||||||||||||||||||||||||||||||
| Primary | Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type. | The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the cancer type. | The numbers of participants per cancer type were displayed. | Posted | Mean | 95% Confidence Interval | Mean cases per month | 21 months |
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| ||||||||||||||||||||||||||||||
| Primary | Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site. | The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the study site. | The numbers of participants per study site were displayed. | Posted | Mean | 95% Confidence Interval | mean cases per month | 21 months |
|
| ||||||||||||||||||||||||||||||
| Primary | Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type | The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the cancer type. | The numbers of participants per cancer type were displayed. | Posted | Mean | 95% Confidence Interval | Mean cases per month | 21 months |
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| ||||||||||||||||||||||||||||||
| Secondary | Information on the Use of Diagnostic Testing in HIV-positive Individuals | The frequency of diagnostic testing modalities will be summarized for cancer. | Posted | Count of Participants | Participants | Up to 21 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer | For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics. | Posted | Count of Participants | Participants | Up to 21 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals | The frequency of the Treatment for Cancers Diagnosed in HIV-positive Individuals will be summarized. | Posted | Count of Participants | Participants | Up to 21 months |
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| Secondary | CD4 of HIV-positive Individuals Diagnosed With Cancer | CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized. | 1 missing CD4 value | Posted | Median | Inter-Quartile Range | Percentage of CD4 cells | Baseline |
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| Secondary | HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer | HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized | 89 participants were assessed for this Outcome Measure. | Posted | Median | Inter-Quartile Range | copies per ml | Baseline |
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Adverse event data were not collected.
No participants were assessed for deaths or adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational (Respond to Surveys, Medical Record Review) | Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deukwoo Kwon | Statistical and Data Analysis Center, AIDS Malignancy Consortium | (713) 500-7964 | deukwoo.kwon@mountsinai.org |
| May 31, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2021 | May 31, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Mexico |
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| Hospital Fernandez (new diagnosis) |
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| Hospital Fernandez (recurrence) |
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| Hospital Fernandez (surveillance) |
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| Hospital Roffo (new diagnosis) |
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| Hospital Roffo (recurrence) |
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| Hospital Roffo (surveillance) |
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| Instituto Nacional De Cancer Brazil (new diagnosis) |
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| Instituto Nacional De Cancer Brazil (recurrence) |
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| Instituto Nacional De Cancer Brazil (surveillance) |
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| Instituto de Oncologia (new diagnosis) |
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| Instituto de Oncologia (recurrence) |
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| Instituto de Oncologia (surveillance) |
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| Title | Denominators | Categories | ||||
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| Kaposi sarcoma |
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| Non-Hodgkin's lymphoma |
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| Hodgkin's lymphoma |
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| Anal |
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| Cervical |
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| Other |
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