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/36107411/Actively Recruiting
Led by Cedars-Sinai Medical Center · Updated on 2026-05-07
216
Participants Needed
1
Research Sites
N/A
Total Duration
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
Active Surveillance of Papillary Thyroid Microcarcinoma
A
Allen Ho, MD
C
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Cedars-Sinai Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Active Surveillance | Immediate Surgery | Current Standard - Lobectomy |
|---|---|---|---|
| What it is | Monitoring selected low‑risk papillary thyroid microcarcinoma over time without immediate surgery | Surgical removal soon after diagnosis as performed in enrolled participants | Current guidelines favour lobectomy for low‑risk papillary thyroid microcarcinoma as standard surgical management |
| Role in trial | One of the two parallel study arms under investigation | Comparator arm in trial receiving immediate surgery | Reflects routine surgical practice outside trial for similar patients |
| Primary use | To observe tumor behavior over years while avoiding or delaying surgery | To remove the microcarcinoma promptly after diagnosis | Definitive surgical removal (lobectomy) of low‑risk microcarcinoma as commonly practiced |
| How it is done | Regular monitoring with imaging and questionnaires without surgery | Surgical removal of thyroid lobe shortly after diagnosis | Lobectomy performed according to current surgical guidelines |
| Evidence status | Long‑term observational data suggest low progression rates over decades | Surgical removal yields very low recurrence or progression | Widely accepted to achieve disease control in low‑risk PTMC |
| Important limitations | Requires long‑term follow‑up and patient adherence; progression, while infrequent, may occur | Irreversible surgery with impact on thyroid function and potential overtreatment for indolent disease | May represent overtreatment for many low‑progression PTMC cases |
| Patient impact | Less surgery‑related side effects and better psychological outcomes in many monitored patients | Immediate removal avoids disease progression but exposes to surgical recovery and lifelong thyroid effects | Common practice provides disease control but may involve unnecessary surgery for many patients |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Allen S Ho, Sungjin Kim, Cynthia Zalt...
https://pubmed.ncbi.nlm.nih.gov/36107411/Cedars-Sinai Medical Center
Lead Sponsor