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

Recruitment status

COMPLETED

Target enrollment

460 participants

Primary outcome timeframe

Enrollment

Results posted on

2026-03-25

Participant Flow

Participant milestones

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

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: 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

Outcome measures

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 weeks

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 measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 weeks

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 (%).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

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 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: Baseline

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 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 weeks

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 weeks

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

The 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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Metastic or Locally Advanced Cancer

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Prior Cancer

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 501 526-6724

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place