Brief Summary
This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.
Brief Title
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
Categories
Completion Date
Completion Date Type
Estimated
Conditions
HIV-Associated Malignant Neoplasm
HIV Infections
Cancer
AIDS Related Lymphoma
AIDS-related Kaposi Sarcoma
AIDS-Related Malignancy
Anal Cancer
HPV-Related Malignancy
Eligibility Criteria
Inclusion Criteria:
* Participant can understand and is willing to sign a written informed consent document.
* HIV positive. Documentation of HIV-1 infection by means of any one of the following:
* Documentation of an HIV diagnosis in the medical record by a licensed health care provider;
* Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the 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 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
* 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 (e.g., U.S. FDA).
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/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.
* Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories:
* New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment
* Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
* Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
* Age ≥ 18 years.
* Participant presents to an AMC domestic clinical trial site for either clinical care or research.
Exclusion Criteria:
* Participants who do not fulfill the criteria as listed above are ineligible.
* Participant can understand and is willing to sign a written informed consent document.
* HIV positive. Documentation of HIV-1 infection by means of any one of the following:
* Documentation of an HIV diagnosis in the medical record by a licensed health care provider;
* Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the 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 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
* 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 (e.g., U.S. FDA).
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/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.
* Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories:
* New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment
* Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
* Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
* Age ≥ 18 years.
* Participant presents to an AMC domestic clinical trial site for either clinical care or research.
Exclusion Criteria:
* Participants who do not fulfill the criteria as listed above are ineligible.
Inclusion Criteria
Inclusion Criteria:
* Participant can understand and is willing to sign a written informed consent document.
* HIV positive. Documentation of HIV-1 infection by means of any one of the following:
* Documentation of an HIV diagnosis in the medical record by a licensed health care provider;
* Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the 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 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
* 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 (e.g., U.S. FDA).
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/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.
* Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories:
* New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment
* Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
* Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
* Age ≥ 18 years.
* Participant presents to an AMC domestic clinical trial site for either clinical care or research.
* Participant can understand and is willing to sign a written informed consent document.
* HIV positive. Documentation of HIV-1 infection by means of any one of the following:
* Documentation of an HIV diagnosis in the medical record by a licensed health care provider;
* Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the 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 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
* 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 (e.g., U.S. FDA).
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/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.
* Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories:
* New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment
* Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
* Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
* Age ≥ 18 years.
* Participant presents to an AMC domestic clinical trial site for either clinical care or research.
Gender
All
Gender Based
false
Keywords
HIV-Related Cancer
AIDS
AIDS-related malignancy
anal cancer
lymphoma
kaposi sarcoma
cervical cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05510908
Org Class
Network
Org Full Name
AIDS Malignancy Consortium
Org Study Id
AMC-115
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AIDS Malignancy Consortium A Trial of the AIDS Malignancy Consortium (AMC)
Primary Outcomes
Outcome Description
For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study:
1. Solid organ tumors associated with human papillomavirus (HPV) infection
2. Solid organ tumors unrelated to HPV
3. Kaposi sarcoma
4. Hematologic malignancies
1. Solid organ tumors associated with human papillomavirus (HPV) infection
2. Solid organ tumors unrelated to HPV
3. Kaposi sarcoma
4. Hematologic malignancies
Outcome Measure
Number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
Outcome Time Frame
Enrollment
Secondary Ids
Secondary Id
UM1CA121947
Secondary Outcomes
Outcome Description
This will be calculated by the number of participants enrolled who meet site-based AMC trial eligibility compared to the number of eligible participants at each site who meet site-based AMC trial eligibility.
Outcome Time Frame
Baseline and 12 weeks
Outcome Measure
Proportion of participants eligible for AMC trials who are successfully enrolled
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Participants with a dual diagnosis of both cancer (current or diagnosed within 5 years) and underlying HIV infection, who present for care at AMC domestic sites.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rafi Kabarriti
Investigator Email
RKABARRI@MONTEFIORE.ORG