An interventional study of Biopsy and Active Monitoring in Thyroid Nodule, Thyroid Neoplasms and Thyroid Cancer, sponsored by Dartmouth-Hitchcock Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment
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:
Inclusion Criteria:
Exclusion Criteria:
Patients who fall into one of the following categories will NOT be eligible for this study:
TRAIL Pilot Integrated QRI: Inclusion/Exclusion Criteria
Inclusion Criteria for Study Patient Participants:
Exclusion Criteria for Study Patient Participants:
-Patients who are not willing to allow audio recorder presence and/or not willing to be interviewed by QRI team will be excluded from this study.
Inclusion Criteria for Study Staff Participants:
Exclusion Criteria for Study Staff Participants:
-Staff members who are not willing to participate in audio taping of recruitment discussions and/or interviews with QRI team about their views of the study will be excluded.
The aim of biopsy is to sample the thyroid nodule so that it can be tested for cancer. A biopsy is done with a small needle in an office. If the biopsy result shows the nodule is unlikely to be cancer, the next step is check-ups every 6 months to a year for two years followed by additional checkups that occur less frequently. If the biopsy result shows the nodule may be cancerous, usual treatment is surgery to remove part or all of the thyroid gland. Afterwards, regular check-ups and ultrasounds follow. Surgery may be outpatient or overnight stay. Recovery takes a couple weeks or more. Time in the hospital and recovering depends on the type of operation and any side-effects.
Procedure: Biopsy
The aim of Active Monitoring is to monitor the thyroid nodule closely. An ultrasound and a check-up with a clinician are done every six months for two years, then less often after that. If no changes in the nodule or new abnormal lymph nodes are seen, Active Monitoring continues and surgery and its side-effects are avoided. If changes in the nodule are seen on ultrasound, they are explained at the visit. The doctor may recommend that continued Active Monitoring or recommend a biopsy to investigate the changes. The biopsy result may suggest Active Monitoring can be continued, or may indicate surgery should be done, as described above.
Procedure: Active Monitoring
Local 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.
Ultrasound 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.
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 randomization
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.
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 randomization
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.
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.
Clinical outcomes; Nodule size
If patient is on active monitoring, then the nodule size will be followed with ultrasound exams.
Time frame: Baseline and 6 months after randomization.
Score on selected domains of the ThyPRO short form instrument
The ThyPRO survey is a quality-of-life measure designed to evaluate how thyroid disease has affected the participant's life. Domains being used from this measure for the pilot study include symptoms (8 items), tiredness (2 items), and memory and concentration (3 items). Answer choices range from 1 (not at all) to 5 (very much) with higher scores indicating worse quality of life.
Time frame: 3 and 6 months post randomization
Plan to share: No
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Dartmouth-Hitchcock Medical Center