Trial Outcomes & Findings for Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT) (NCT NCT05029752)
NCT ID: NCT05029752
Last Updated: 2026-07-15
Results Overview
Completion of assessment by at least 70% of participants
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
1 day
Results posted on
2026-07-15
Participant Flow
Participant milestones
| Measure |
Healthy HCT Donors - Cohort 1
Healthy HCT Donors age 6 to \</=14 years
|
HCT Candidates or Recipients - Cohort 1
HCT Candidates or Recipients age 6 to \</=14 years
|
Healthy HCT Donors - Cohort 2
Healthy HCT Donors age \>14 years to 26 years
|
HCT Candidates or Recipients - Cohort 2
HCT Candidates or Recipients age \>14 years to 26 years
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
9
|
4
|
13
|
|
Overall Study
COMPLETED
|
1
|
6
|
4
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
4
|
Reasons for withdrawal
| Measure |
Healthy HCT Donors - Cohort 1
Healthy HCT Donors age 6 to \</=14 years
|
HCT Candidates or Recipients - Cohort 1
HCT Candidates or Recipients age 6 to \</=14 years
|
Healthy HCT Donors - Cohort 2
Healthy HCT Donors age \>14 years to 26 years
|
HCT Candidates or Recipients - Cohort 2
HCT Candidates or Recipients age \>14 years to 26 years
|
|---|---|---|---|---|
|
Overall Study
Unable to complete assessment
|
0
|
3
|
0
|
4
|
Baseline Characteristics
Feasibility of Digital Thermal Monitoring to Assess Endothelium-Dependent Vasodilation in Patients Undergoing Hematopoietic Cell Transplantation (HCT)
Baseline characteristics by cohort
| Measure |
Healthy HCT Donors - Cohort 1
n=1 Participants
Healthy HCT Donors age 6 to \</=14 years
|
HCT Candidates or Recipients - Cohort 1
n=9 Participants
HCT Candidates or Recipients age 6 to \</=14 years
|
Healthy HCT Donors - Cohort 2
n=4 Participants
Healthy HCT Donors age \>14 years to 26 years
|
HCT Candidates or Recipients - Cohort 2
n=13 Participants
HCT Candidates or Recipients age \>14 years to 26 years
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
18 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=20 Participants
|
9 participants
n=20 Participants
|
4 participants
n=40 Participants
|
13 participants
n=5 Participants
|
27 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 1 dayCompletion of assessment by at least 70% of participants
Outcome measures
| Measure |
All Participants
n=27 Participants
All consented patients
|
|---|---|
|
Feasibility of the Use of VENDYS-II in Children and AYA as a Measure of Vascular Endothelial Function
|
20 Participants
|
Adverse Events
Healthy HCT Donors - Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HCT Candidates or Recipients - Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy HCT Donors - Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HCT Candidates or Recipients - Cohort 1
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
Keri L Schadler, PhD
The University of Texas MD Anderson Cancer Center
Phone: (713) 794-1035
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place