HIV-Associated Malignant NeoplasmNCT05510908
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
An observational study of HIV-Associated Malignant Neoplasm and HIV Infections, run by AIDS Malignancy Consortium at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-Associated Malignant Neoplasm, HIV Infections, Cancer
- What is being tested?
- Non-Interventional and Non-Interventional Follow-up
- How many people
- 460 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 25 Jul 2023to 2 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- Participants who do not fulfill the criteria as listed above are ineligible.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
University of Illinois at Chicago
Chicago, Illinois, 60612
The Ohio State University
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
Moores UCSD Cancer Center
La Jolla, California, 92903
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Weill Cornell Medicine - Cornell Clinical Trials Unit
New York, New York, 10010
Mount Sinai Hospital
New York, New York, 10029
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, 84112
Virginia Mason Medical Center
Seattle, Washington, 98101
Washington University School of Medicine
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
George Washington University Cancer Center
Washington D.C., District of Columbia, 20037
About this study
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)
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.
Read the detailed description
Primary Objective: To estimate the number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
Secondary Objectives: To characterize participants that are eligible but not enrolled onto AMC clinical trials to understand site-specific and trial-specific accrual barriers
Exploratory Objectives: 1. To standardize and expand the quantity and quality of sociodemographic and cancer diagnostic and treatment characteristics collected for PWH receiving care at domestic AMC sites. 2. To describe cancer patient health-related QOL for PWH at domestic AMC sites using validated tools: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Outline: Participants identified via screening of electronic medical records or institutional databases. All eligible participants attend one visit for the collection of broad demographic and clinical data. Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit. Data collection at study visits will occur via survey procedures and/or medical record review.
- Conditions
- HIV-Associated Malignant Neoplasm, HIV Infections, Cancer, AIDS Related Lymphoma, AIDS-related Kaposi Sarcoma, AIDS-Related Malignancy
- Being tested
- Non-Interventional, Non-Interventional Follow-up
- Keywords
- HIV-Related Cancer, AIDS, AIDS-related malignancy, anal cancer, lymphoma, kaposi sarcoma, cervical cancer
- Medical subject headings
- HIV Infections, Neoplasms, Lymphoma, AIDS-Related, AIDS-related Kaposi sarcoma, Anus Neoplasms, Acquired Immunodeficiency Syndrome, Lymphoma, Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-upOther
Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
| Study group | Role | What they receive |
|---|---|---|
| New, primary or recurrent disease | Considering or currently receiving cancer treatment Receives: Other: Non-Interventional; Other: Non-Interventional Follow-up | |
| Metastic 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. Receives: Other: Non-Interventional; Other: Non-Interventional Follow-up | |
| Prior cancer | Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
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:
- Solid organ tumors associated with human papillomavirus (HPV) infection
- Solid organ tumors unrelated to HPV
- Kaposi sarcoma
- Hematologic malignancies
Measured: Enrollment
Secondary outcomes (1)
Percentage of Participants Eligible for AMC Trials Who Are Successfully Enrolled
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start25 Jul 2023
- Primary completion28 Feb 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-Associated Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna E Coghill, PhD, MPH, Study chair, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510908
- Sponsor's protocol ID
- AMC-115
- Other IDs
- UM1CA121947
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2022
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05510908
- Acronym / sponsor ID
- AMC-115
- Conditions
- HIV-Associated Malignant Neoplasm, HIV Infections, Cancer, AIDS Related Lymphoma, AIDS-related Kaposi Sarcoma, AIDS-Related Malignancy
- Keywords
- HIV-Related Cancer, AIDS, AIDS-related malignancy, anal cancer, lymphoma, kaposi sarcoma, cervical cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective: To estimate the number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
Secondary Objectives: To characterize participants that are eligible but not enrolled onto AMC clinical trials to understand site-specific and trial-specific accrual barriers
Exploratory Objectives: 1. To standardize and expand the quantity and quality of sociodemographic and cancer diagnostic and treatment characteristics collected for PWH receiving care at domestic AMC sites. 2. To describe cancer patient health-related QOL for PWH at domestic AMC sites using validated tools: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Outline: Participants identified via screening of electronic medical records or institutional databases. All eligible participants attend one visit for the collection of broad demographic and clinical data. Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit. Data collection at study visits will occur via survey procedures and/or medical record review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New, primary or recurrent disease | – | Other: Non-Interventional, Other: Non-Interventional Follow-upConsidering or currently receiving cancer treatment |
| Metastic or locally advanced cancer | – | Other: Non-Interventional, Other: Non-Interventional Follow-upThis 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 cancer | – | Other: Non-InterventionalPrior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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:
- 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:
Key exclusion criteria (1 listed)
- Participants who do not fulfill the criteria as listed above are ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalParticipants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review. | Other | Metastic or locally advanced cancer, New, primary or recurrent disease, Prior cancer |
| Non-Interventional Follow-upParticipants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review. | Other | Metastic or locally advanced cancer, New, primary or recurrent disease |
Primary outcome
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Time frame: Enrollment
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 secondary outcome
Percentage of Participants Eligible for AMC Trials Who Are Successfully Enrolled
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna E Coghill, PhD, MPH study chair
AIDS Malignancy Consortium
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-Associated Malignant Neoplasm and HIV Infections, run by AIDS Malignancy Consortium at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites (time frame: Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.