Trial Outcomes & Findings for Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies (NCT NCT01567722)
NCT ID: NCT01567722
Last Updated: 2023-03-16
Results Overview
Summary of the specimens available by study arm
Recruitment status
TERMINATED
Target enrollment
114 participants
Primary outcome timeframe
Study entry (prior to chemotherapy initiation)
Results posted on
2023-03-16
Participant Flow
Participant milestones
| Measure |
HIV-positive Diffuse Large B-cell Lymphoma Cases
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.
|
HIV-positive Lung Cancer Cases
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
|
Cervical Cancer
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer.
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
19
|
2
|
|
Overall Study
COMPLETED
|
87
|
19
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
0
|
Reasons for withdrawal
| Measure |
HIV-positive Diffuse Large B-cell Lymphoma Cases
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.
|
HIV-positive Lung Cancer Cases
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
|
Cervical Cancer
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer.
|
|---|---|---|---|
|
Overall Study
Not being able to get tissue for Central Pathology Review prior to the protocol closure date
|
1
|
0
|
0
|
|
Overall Study
Insufficient tissue available to satisfy the protocol requirements
|
2
|
0
|
0
|
|
Overall Study
Protocol closure by the OCG
|
2
|
0
|
0
|
|
Overall Study
Not enough tissue left for the tissue scrolls
|
1
|
0
|
0
|
Baseline Characteristics
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
Baseline characteristics by cohort
| Measure |
HIV-positive Diffuse Large B-cell Lymphoma Cases
n=93 Participants
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.
|
HIV-positive Lung Cancer Cases
n=19 Participants
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
|
HIV Positive Cervical Cancer Cases
n=2 Participants
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.10 years
STANDARD_DEVIATION 10.86 • n=99 Participants
|
61.42 years
STANDARD_DEVIATION 6.22 • n=107 Participants
|
49.50 years
STANDARD_DEVIATION 7.78 • n=206 Participants
|
51.97 years
STANDARD_DEVIATION 10.99 • n=7 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
93 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Study entry (prior to chemotherapy initiation)Summary of the specimens available by study arm
Outcome measures
| Measure |
HIV-positive Diffuse Large B-cell Lymphoma Cases
n=93 Participants
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.
|
HIV-positive Lung Cancer Cases
n=19 Participants
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
|
HIV Positive Cervical Cancer Cases
n=2 Participants
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and cervical cancer.
|
|---|---|---|---|
|
Collection of Tissue Specimen From Study Participants
Snap frozen biopsy
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Collection of Tissue Specimen From Study Participants
Formalin-fixed, paraffin-embedded for genomic sequence analysis
|
13 Participants
|
5 Participants
|
0 Participants
|
|
Collection of Tissue Specimen From Study Participants
Central pathology review
|
85 Participants
|
18 Participants
|
2 Participants
|
|
Collection of Tissue Specimen From Study Participants
Formalin-fixed, paraffin-embedded tissue block for cental pathology review
|
39 Participants
|
7 Participants
|
0 Participants
|
|
Collection of Tissue Specimen From Study Participants
Unstained slide from tissue
|
65 Participants
|
12 Participants
|
2 Participants
|
|
Collection of Tissue Specimen From Study Participants
Specimen for Genomic sequence analysis
|
71 Participants
|
16 Participants
|
2 Participants
|
|
Collection of Tissue Specimen From Study Participants
Hematoxylin and eosin stained slide
|
8 Participants
|
3 Participants
|
1 Participants
|
|
Collection of Tissue Specimen From Study Participants
Peripheral Blood Mononuclear Cells
|
68 Participants
|
14 Participants
|
1 Participants
|
|
Collection of Tissue Specimen From Study Participants
Tissue core
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Collection of Tissue Specimen From Study Participants
Tissue scroll
|
9 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
HIV-positive Diffuse Large B-cell Lymphoma Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV-positive Lung Cancer Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Positive Cervical Cancer Cases
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60