Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06220656
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2023-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TRAIL Study: Feasibility and Pilot
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Study Overview
Official Title:
ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study to compare two ways of managing newly identified thyroid nodules that are likely to be cancerous based on ultrasound result and which under usual care would undergo immediate biopsy.
The main goals of this pilot study are 1) compare anxiety at 6 months in each treatment arm using the validated instrument Anxiety-CA, 2) measure thyroid quality of life in each treatment arm
Participants will be randomized to one of two groups:
1. immediate biopsy (usual care)
2. Active monitoring (serial ultrasound based monitoring and close clinical follow-up)
The main goals of this pilot study are 1) compare anxiety at 6 months in each treatment arm using the validated instrument Anxiety-CA, 2) measure thyroid quality of life in each treatment arm
Participants will be randomized to one of two groups:
1. immediate biopsy (usual care)
2. Active monitoring (serial ultrasound based monitoring and close clinical follow-up)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 23DAV058 | OTHER | Dartmouth Cancer Center | View |