TRAIL Study: Feasibility and Pilot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be ≥18 years of age.
Participants must be able and willing to provide informed consent or have a surrogate capable of providing same.
Participants must be absent of symptoms referable to the nodule: dysphagia or nodule physically visible and/or bothersome to patient.
Participants' thyroid nodule must have a TI-RADS rating of 4 or 5.
Disqualifiers
Adults who are unable to provide informed consent.
Patients for whom biopsy is not a consideration.
Patients with a prior history of thyroid cancer other than papillary thyroid cancer.
Patients with a history of radiation to the neck.
Trial design
Design model
Parallel
Treatments tested in this trial
Biopsy
Procedure/SurgeryLocal anesthetic is usually given and a small needle is used to take cells from the thyroid under ultrasound guidance through several 'passes' and placed into specialized media for pathology evaluation.
Active Monitoring
Procedure/SurgeryUltrasound and a check-up at 6 months. Depending on ultrasound results, either biopsy and further care (as for the treatment arm called 'biopsy'), or continue with active monitoring.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Immediate biopsy (usual care)Experimental treatment 1 intervention
Group B: Active monitoring, proceeding to biopsy if neededExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Anxiety at 6 months
Rate of anxiety will be measured using Anxiety-CA instrument PROMIS-Anxiety Short form. Each question has five response options ranging in value from one to five. (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the adult PROMIS Anxiety 7a short form, a raw score of 10 converts to a T-score of 46.7 with a standard error (SE) of 2.6.
Time frame
6 months after randomizationSecondary outcomes
1
Representativeness of enrolled participants compared to eligible participants
Representativeness will be compared in terms of age in years (continuous), biological male or female (categorical), and race/ethnicity (categorical).
Time frame
6 months after randomization.2
Study Procedure compliance
Rate of completion of patient reported outcomes and number of participants who withdraw from study or are lost to follow-up.
Time frame
6 months after randomization3
Clinical outcomes: needle biopsy cytology results (if done),
A needle biopsy is a procedure to obtain samples of tissue or cells from thyroid nodule or lymph nodes to reveal whether a nodule is a benign tumor or cancer. Bethesda classification (ordinal) will be used. The Bethesda system identifies six diagnostic categories on thyroid nodule cytopathology. Each category is linked to a malignancy risk. Categories are as follows: Category I (Nondiagnostic), Category II (Benign), Category III (Atypical of undetermined significance), Category IV (Suspicious for follicular neoplasm), Category V (suspicious for malignancy), Category VI (Malignant). If Cytology results shows Bethesda V or VI, then histology (categorical) will be performed.
Time frame
6 months after randomization.4
Clinical outcomes: pathology at surgery (if surgery performed),
Histologic examination (Categorical) will be performed to make diagnosis. Histology is a medical practice to review tissues under microscope to identify potential changes in a suspected tissue. The histological exam will help to diagnose if cancer is present or not and to find out the histologic type of the suspected tissue. The histologic types for thyroid cancer are as follows: Papillary, follicular, oncocytic, medullary, and anaplastic.
Time frame
6 months after randomization.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
American College of Radiology
Collaborator
Dartmouth College
Collaborator
Source ClinicalTrials.gov