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NCT Number: NCT02609685

Active Surveillance of Papillary Thyroid Microcarcinoma

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Allen Ho, MD

CONTACT

[email protected]

310-423-1220

Allen Ho, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Surveillance

Other

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

Primary outcomes

  1. Rate of disease progression

    Time frame: From time of diagnosis up to10 years of follow-up

Secondary outcomes

  1. 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

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

    Time frame: Five years

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

    Time frame: Five years

  4. 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.

  5. Quality of life score as measured by City of Hope Quality of Life Scale

    Time frame: Up to five years

  6. Anxiety score as measured by Memorial Anxiety Scale

    Time frame: Up to five years

Study contacts

Contact information is provided by the study sponsor or research team.

Allen Ho, MD

CONTACT

[email protected]

310-423-1220

Clinical Trials Navigator

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Acronym: PMCAS

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Nov 20, 2015
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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