Expanded Parameters in Active Surveillance for Low-risk Papillary Thyroid Carcinoma: A Nonrandomized Controlled Trial.
Allen S Ho, Sungjin Kim, Cynthia Zalt...
https://pubmed.ncbi.nlm.nih.gov/36107411Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02609685
Active Surveillance of Papillary Thyroid Microcarcinoma
Led by Cedars-Sinai Medical Center · Updated on 2026-05-07
216
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand the outcomes of active surveillance, which means careful observation without immediate surgery, for patients with papillary thyroid microcarcinoma (PTMC). PTMC is a type of thyroid cancer involving nodules 1.5 cm or smaller. The study focuses on monitoring disease progression over 3, 5, and 10 years and compares quality of life and anxiety between patients who choose active surveillance and those who opt for immediate surgery. Participants in the active surveillance group will be closely monitored every six months until their disease remains stable for two years, after which monitoring occurs annually. Those who choose immediate surgery can join a sub-study that evaluates quality of life and anxiety but do not receive any additional intervention as surgery is the standard care. Participants can switch to surgery at any time if they and their doctors decide it is best. Throughout the study, patients will undergo regular assessments including ultrasound imaging to track tumor size and disease progression. Researchers will gather data on genetic and clinical factors that may affect progression, as well as quality of life and anxiety scores. The study may last up to 10 years, with close follow-up to measure the rate of disease progression and the impact of different management choices.
CONDITIONS
Brief Title
Active Surveillance of Papillary Thyroid Microcarcinoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed Bethesda III or IV nodules with BRAF mutation
- Thyroid nodules 2.0 cm or smaller by ultrasound
- Ability to understand and willingness to sign informed consent and HIPAA authorization
- Must be able to read and write English fluently to participate in questionnaires
You will not qualify if you...
- High-grade or poorly differentiated papillary thyroid carcinoma variants
- Central or lateral neck lymphadenopathy suspicious for papillary thyroid carcinoma
- Unfavorable nodule location near critical structures such as the recurrent laryngeal nerve or trachea
- History of radiation to the neck
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Active Surveillance
Duration - Up to 10 years
Participants are closely monitored every six months until their disease is stable for two years, then annually thereafter to watch for any progression of papillary thyroid microcarcinoma.
Visits every 6 months for 2 years, then annual visits thereafter
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
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Research Team
A
Allen Ho, MD
C
Clinical Trials Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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