Active Surveillance of Papillary Thyroid Microcarcinoma (PMCAS)

April 1, 2024 updated by: Allen Ho, Cedars-Sinai Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of thyroid cancer has more than doubled in the last 30 years in the United States, Europe, Canada, and South America. Since nearly 50% of this increase is attributable to papillary thyroid microcarcinomas (PTMC), it appears that greater detection and diagnosis of previously subclinical disease is a major factor driving this dramatic rise.

The primary objective is to estimate the rate of disease progression (growth of primary tumor or development of loco-regional/distant metastases) over a 3, 5, and 10-year period in a series of PTMC patients followed with active surveillance in the United States.

Patients who opt for immediate surgery can participate in a sub-study looking at quality of life and anxiety measures as compared to those patients who enroll in the active surveillance main study. Patients who enroll in active surveillance can choose to have surgery at any time that they and their treating physician feel that it is in their best interest.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Allen Ho, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 2.0 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Active Surveillance
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
Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.
No Intervention: Immediate Surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of disease progression
Time Frame: From time of diagnosis up to10 years of follow-up
From time of diagnosis up to10 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects that will elect surgery despite absence of clinical progression
Time Frame: From time of diagnosis up to 10 years of follow-up
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
Time Frame: Five years
Five years
Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance
Time Frame: Five years
Five years
Identify the genetic factors associated with an increased risk of disease progression
Time Frame: Five years
At any time subjects who have enrolled in the active surveillance study can opt to have surgery. Data will be taken from diagnosis to just after surgery.
Five years
Quality of life score as measured by City of Hope Quality of Life Scale
Time Frame: Up to five years
Up to five years
Anxiety score as measured by Memorial Anxiety Scale
Time Frame: Up to five years
Up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Allen Ho, MD, Cedars-Sinal Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimated)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2014-13-Ho-PMCAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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