Active Surveillance of Papillary Thyroid Microcarcinoma

NCT02609685 | Recruiting

• 1 other identifier: IIT2014-13-Ho-PMCAS
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.

Conditions

Papillary Thyroid Microcarcinoma

Keywords

Thyroid cancer; Active surveillance; PTMC

Outcome Measures

Primary Outcomes (1)

• Rate of disease progression

  From time of diagnosis up to10 years of follow-up

Secondary Outcomes (6)

• Percentage of subjects that will elect surgery despite absence of clinical progression

  From time of diagnosis up to 10 years of follow-up

• Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound

  Five years

• Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance

  Five years

• Identify the genetic factors associated with an increased risk of disease progression

  Five years

• Quality of life score as measured by City of Hope Quality of Life Scale

  Up to five years

Study Arms (2)

Active Surveillance

OTHER

Active surveillance instead of standard of care immediate surgery. Patients will be closely monitored every six months until disease is stable for a two-year period and then annually thereafter.

Other: Active Surveillance

Immediate Surgery

NO INTERVENTION

Patients who choose to get surgery immediately after diagnosis may choose to enroll in a questionnaire sub-study that will compare quality of life and anxiety scores to patients who enroll in the active surveillance study. This is considered "no intervention" because the protocol is not directing treatment. Surgery is the standard treatment for papillary thyroid microcarcinoma.

Interventions

Active Surveillance OTHER

Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.

Active Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• cm or smaller nodules by ultrasonographic criteria
• Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form
• Must be able to read and write English fluently to participate in the questionnaire portion of the study

You may not qualify if:

• High-grade or poorly differentiated PTC variants
• Central or lateral neck lymphadenopathy suspicious for PTC
• Unfavorable nodule location (e.g. Near dorsal surface (by recurrent laryngeal nerve); Adjacent to trachea (risk of cartilage invasion)
• History of radiation to neck

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (1)

• Ho AS, Kim S, Zalt C, Melany ML, Chen IE, Vasquez J, Mallen-St Clair J, Chen MM, Vasquez M, Fan X, van Deen WK, Haile RW, Daskivich TJ, Zumsteg ZS, Braunstein GD, Sacks WL. Expanded Parameters in Active Surveillance for Low-risk Papillary Thyroid Carcinoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2022 Sep 15;8(11):1588-96. doi: 10.1001/jamaoncol.2022.3875. Online ahead of print.

  PMID: 36107411 DERIVED

MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma; Thyroid Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Allen Ho, MD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allen Ho, MD

CONTACT

310-423-1220; Allen.Ho@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head and Neck Cancer Program and Co-Director, Thyroid Cancer Program

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: May 13, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)