Trial Outcomes & Findings for Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC (NCT NCT05510908)
NCT ID: NCT05510908
Last Updated: 2026-03-25
Results Overview
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
COMPLETED
460 participants
Enrollment
2026-03-25
Participant Flow
Participant milestones
| Measure |
New, Primary or Recurrent Disease
Considering or currently receiving cancer treatment
Non-Interventional: 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-up: 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.
|
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.
Non-Interventional: 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-up: 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.
|
Prior Cancer
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
268
|
33
|
159
|
|
Overall Study
COMPLETED
|
268
|
33
|
159
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
Baseline characteristics by cohort
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: 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-up: 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.
|
Metastic or Locally Advanced Cancer
n=33 Participants
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.
Non-Interventional: 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-up: 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.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: 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.
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=138 Participants
|
59 years
n=62 Participants
|
59 years
n=123 Participants
|
57 years
n=158 Participants
|
|
Sex/Gender, Customized
Female
|
37 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
31 Participants
n=123 Participants
|
71 Participants
n=158 Participants
|
|
Sex/Gender, Customized
Male
|
221 Participants
n=138 Participants
|
30 Participants
n=62 Participants
|
125 Participants
n=123 Participants
|
376 Participants
n=158 Participants
|
|
Sex/Gender, Customized
Transgender
|
4 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
6 Participants
n=158 Participants
|
|
Sex/Gender, Customized
Not reported/Unknown
|
6 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
7 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=138 Participants
|
4 Participants
n=62 Participants
|
45 Participants
n=123 Participants
|
111 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
199 Participants
n=138 Participants
|
29 Participants
n=62 Participants
|
107 Participants
n=123 Participants
|
335 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
14 Participants
n=158 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
5 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
3 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Black or African American
|
101 Participants
n=138 Participants
|
17 Participants
n=62 Participants
|
61 Participants
n=123 Participants
|
179 Participants
n=158 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=138 Participants
|
15 Participants
n=62 Participants
|
70 Participants
n=123 Participants
|
210 Participants
n=158 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
26 Participants
n=123 Participants
|
59 Participants
n=158 Participants
|
|
Education
Never attended school
|
2 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
3 Participants
n=158 Participants
|
|
Education
High school graduate or below
|
57 Participants
n=138 Participants
|
7 Participants
n=62 Participants
|
48 Participants
n=123 Participants
|
112 Participants
n=158 Participants
|
|
Education
College degree or equivalent
|
77 Participants
n=138 Participants
|
11 Participants
n=62 Participants
|
47 Participants
n=123 Participants
|
135 Participants
n=158 Participants
|
|
Education
Unknown/not reported
|
132 Participants
n=138 Participants
|
15 Participants
n=62 Participants
|
63 Participants
n=123 Participants
|
210 Participants
n=158 Participants
|
|
Smoking history
Current use
|
54 Participants
n=138 Participants
|
10 Participants
n=62 Participants
|
31 Participants
n=123 Participants
|
95 Participants
n=158 Participants
|
|
Smoking history
Quit/former use
|
111 Participants
n=138 Participants
|
11 Participants
n=62 Participants
|
57 Participants
n=123 Participants
|
179 Participants
n=158 Participants
|
|
Smoking history
Never used
|
102 Participants
n=138 Participants
|
12 Participants
n=62 Participants
|
70 Participants
n=123 Participants
|
184 Participants
n=158 Participants
|
|
Smoking history
Unknown
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
2 Participants
n=158 Participants
|
PRIMARY outcome
Timeframe: EnrollmentFor 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
Outcome measures
| Measure |
New, Primary or Recurrent Disease
n=268 Participants
Considering or currently receiving cancer treatment
Non-Interventional: 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-up: 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.
|
Metastic or Locally Advanced Cancer
n=33 Participants
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.
Non-Interventional: 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-up: 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.
|
Prior Cancer
n=159 Participants
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional: 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.
|
|---|---|---|---|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Solid organ tumor associated with HPV infection
|
30 Participants
|
10 Participants
|
32 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Hematologic malignancies
|
43 Participants
|
0 Participants
|
35 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Kaposi sarcoma
|
87 Participants
|
6 Participants
|
15 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Solid organ tumors unrelated HPV
|
55 Participants
|
13 Participants
|
55 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Other
|
52 Participants
|
4 Participants
|
22 Participants
|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThis 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 measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksThe 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 (%).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineEORTC 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 successful enrollment versus not. 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineSupportive 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 successful enrollment versus not. 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksEORTC 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksSupportive 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThe frequency of planned cancer treatment regimens (at baseline) successfully initiated will be summarized.
Outcome measures
Outcome data not reported
Adverse Events
New, Primary or Recurrent Disease
Metastic or Locally Advanced Cancer
Prior Cancer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Deukwoo Kwon
Consortium for Advancing Management and Prevention of Cancer in People with HIV
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place