Recruiting

Observational Study

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02609685

Conditions

Papillary Thyroid Microcarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active Surveillance

Study Details

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

Study ID

NCT02609685

Start date

May 13, 2016

Status verified date

May, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

216 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Active Surveillance

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

Primary outcome measure

  • Rate of disease progression [ Time Frame: From time of diagnosis up to10 years of follow-up ]

Central Contacts and Locations

Central contacts

Allen Ho, MD

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

Clinical Trials Navigator

GroupCancerTrialInformation@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Allen Ho, MD

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

Principal Investigator:

Allen Ho, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Thyroid cancer
  • Active surveillance
  • PTMC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-05-07.