Skip to content
Triangle logo TriangleGet started
← Study library

NCT05510908 · REGISTRY CONDITION SEARCH

Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2026-08-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites

→

outcome · POSTED

Proportion of Participants Eligible for AMC Trials Who Are Successfully Enrolled

→

outcome · POSTED

Describe the Cancer Diagnostics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.

→

outcome · POSTED

Describe the Gender Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.

→

outcome · POSTED

Describe the Age Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.

→

outcome · POSTED

Describe the Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.

→

outcome · POSTED

Planned Cancer Therapy for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment

→

outcome · POSTED

Describe the Health-related QOL of Cancer Patients With HIV at Domestic AMC Sites Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]

→

outcome · POSTED

Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]

→

outcome · POSTED

Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]

→

outcome · POSTED

Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
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.
healthy Volunteers
false
minimum Age
18 Years
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. ADULT
  2. 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.
Treatment arms and interventions
arm Groups
  1. description
    Considering or currently receiving cancer treatment
    intervention Names
    1. Other: Non-Interventional
    2. Other: Non-Interventional Follow-up
    label
    New, primary or recurrent disease
  2. description
    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.
    intervention Names
    1. Other: Non-Interventional
    2. Other: Non-Interventional Follow-up
    label
    Metastic or locally advanced cancer
  3. description
    Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
    intervention Names
    1. Other: Non-Interventional
    label
    Prior cancer
interventions
  1. arm Group Labels
    1. Metastic or locally advanced cancer
    2. New, primary or recurrent disease
    3. Prior cancer
    description
    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.
    name
    Non-Interventional
    type
    OTHER
  2. arm Group Labels
    1. Metastic or locally advanced cancer
    2. New, primary or recurrent disease
    description
    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.
    name
    Non-Interventional Follow-up
    type
    OTHER
Study design
observational Model
COHORT
time Perspective
PROSPECTIVE
Enrollment
count
460
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    The distribution of participant cancer diagnosis variable will be summarized.
    measure
    Describe the Cancer Diagnostics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
    time Frame
    Baseline
  2. description
    The distribution of participant gender variable will be summarized.
    measure
    Describe the Gender Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
    time Frame
    Baseline
  3. description
    The distribution of participant characteristics will be summarized. Continuous variables \[e.g. age, height, weight\] will be summarized as mean (std) if they are normally distributed, otherwise they will be summarized as median (IQR). Categorical variables \[e.g. tobacco use, ART medications, comorbidities\] will be summarized as frequency (%).
    measure
    Describe the Age Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
    time Frame
    Baseline and 12 weeks
  4. description
    The distribution of participant cancer treatment at enrollment will be summarized.
    measure
    Describe the Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
    time Frame
    Baseline
  5. description
    The frequency of planned cancer treatment regimens (at baseline) successfully initiated will be summarized.
    measure
    Planned Cancer Therapy for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment
    time Frame
    12 weeks
  6. description
    EORTC QLQ-C30 subscale and overall scores will be used to describe participant symptom and health-related quality of life burden. Baseline EORTC QLQ-C30 scores will be compared according to cancer group. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and single items assessing additional symptoms and perceived financial impact of the disease. Most questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.
    measure
    Describe the Health-related QOL of Cancer Patients With HIV at Domestic AMC Sites Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
    time Frame
    Baseline
  7. description
    Supportive Care Needs Survey Short Form 34 \[SCNS-SF34\] scores will be used to categorize participants based on the degree to which their needs are met. Baseline SCNS-SF34 scores will be compared according to cancer group. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need); with a higher score indicating a higher level of need.
    measure
    Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
    time Frame
    Baseline
  8. description
    EORTC QLQ-C30 will be summarized, both overall and at the \~12-week follow-up, according to participant characteristics and cancer groups. Overall change in QOL will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role,cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms and perceived financial impact of the disease. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.
    measure
    Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
    time Frame
    Baseline and 12 weeks
  9. description
    Supportive Care Needs Short Survey Form 34 \[SCNS-SF34\] scores will be summarized, both overall and at the \~12-week follow-up, according to participant characteristics and cancer groups. Overall change in scores will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need). Scores are averaged, and transformed to 0-100 scale;, with a higher score indicating a higher level of need.
    measure
    Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
    time Frame
    Baseline and 12 weeks
primary Outcomes
  1. 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
    measure
    Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
    time Frame
    Enrollment
secondary Outcomes
  1. 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.
    measure
    Proportion of Participants Eligible for AMC Trials Who Are Successfully Enrolled
    time Frame
    Baseline
Full study description
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.
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-9111f64709e4990346b5
      requested nct id
      NCT05510908
      primary nct id
      NCT05510908
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a8469a8cca20a75ce4fa980eaab4ff20f62c99f2a2e732f1bd42590d1d5dbe14
      payload sha256
      9a0a01bffd25f962093025eeeb0a55e58e1ef04b3599e1e400e1fd386e192b29
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-9111f64709e4990346b5
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT05510908
      occurrences
      1. context exact
        NCT05510908
        end
        11
        exact text
        NCT05510908
        start
        0
      offset unit
      unicode_code_points
      query cond
      AIDS-Related Lymphoma
      query disease state id
      ds-aids-related-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-aids-related-lymphoma-000.json
      source file sha256
      a8469a8cca20a75ce4fa980eaab4ff20f62c99f2a2e732f1bd42590d1d5dbe14
      source json pointer
      /studies/23/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      45b31670200929c70b65313bd81468716960d47c885a8349a5c07b7ebe2c6481
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-9bef21f8032a2937bf7b
      requested nct id
      NCT05510908
      primary nct id
      NCT05510908
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      payload sha256
      b1e4eadec5b6cd79580176596ed87c1eccb32e7896891352c1e33dd9d6674546
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-9bef21f8032a2937bf7b
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT05510908
      occurrences
      1. context exact
        NCT05510908
        end
        11
        exact text
        NCT05510908
        start
        0
      offset unit
      unicode_code_points
      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      source json pointer
      /studies/41/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      45b31670200929c70b65313bd81468716960d47c885a8349a5c07b7ebe2c6481

    Preserved source evidence · Not medical advice