Trial Outcomes & Findings for Families-At-risk for Interstitial Lung Disease Study (NCT NCT03641742)
NCT ID: NCT03641742
Last Updated: 2023-11-18
Results Overview
The visual identification of the presence of ILA (Interstitial Lung Abnormalities) on CT chest scan by a thoracic radiologist.
Recruitment status
COMPLETED
Target enrollment
125 participants
Primary outcome timeframe
During imaging (up to 1 hour)
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
FAR-ILD Proband Participants
Historic data (from medical records) were reviewed.
|
FAR-ILD "At-Risk" Participants
Individuals underwent CT chest imaging and Pulmonary Function testing.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
98
|
|
Overall Study
COMPLETED
|
27
|
98
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only 18 of 57 probands signed consent forms; their data is included here.
Baseline characteristics by cohort
| Measure |
FAR-ILD Proband Participants
n=27 Participants
Historic data (from medical records) were reviewed.
|
FAR-ILD "At-Risk" Participants
n=98 Participants
Individuals underwent CT chest imaging and Pulmonary Function testing.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
52 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
25 Participants
n=7 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
30 Participants
n=5 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
73 Participants
n=7 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
95 Participants
n=5 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
0 Participants
n=7 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
0 Participants
n=5 Participants • Only 18 of 57 probands signed consent forms; their data is included here.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
98 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Interstitial Lung Abnormality (ILA)
|
27 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During imaging (up to 1 hour)The visual identification of the presence of ILA (Interstitial Lung Abnormalities) on CT chest scan by a thoracic radiologist.
Outcome measures
| Measure |
FAR-ILD "At Risk" Participants Without ILA
n=98 Participants
The number of "At Risk" Participants whose Chest CT imaging, which was obtained as part of this study, did not show Interstitial Lung Abnormalities (ILA)
|
FAR-ILD "At-Risk" Participants With ILA
n=98 Participants
The number of "At Risk" Participants whose CT imaging, which was obtained as part of this study, showed evidence of Interstitial Lung Abnormalities (ILA)
|
|---|---|---|
|
Number of Participants With ILA (Interstitial Lung Abnormalities)
|
85 Participants
|
13 Participants
|
Adverse Events
FAR-ILD Proband With an Adverse Event
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
FAR-ILD "At-Risk" Participant With and Adverse Event
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FAR-ILD Proband With an Adverse Event
n=27 participants at risk
Any adverse event resulting from participation in the study.
|
FAR-ILD "At-Risk" Participant With and Adverse Event
n=98 participants at risk
Any adverse event resulting from participation in the study.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death due to respiratory cause
|
3.7%
1/27 • Number of events 1 • Adverse event data collected through study completion, an average of 1 year.
|
0.00%
0/98 • Adverse event data collected through study completion, an average of 1 year.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christine Kim Garcia
Columbia University Irving Medical Center
Phone: 2123058203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place