Active Surveillance of Papillary Thyroid Microcarcinoma

What is the Purpose of this Study?

This study focuses on individuals with papillary thyroid cancer with a 2.0 cm or smaller nodule. The purpose of the 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).

PTMC is considered low-risk for disease progression. Previous studies have shown that patients who were closely observed and those who received immediate surgery showed similar results for progression-free survival over a long-term follow up. This could mean that observation of PTMC is a safe and acceptable alternative to immediate surgery.

Participants in this study have either 1) agreed to undergo active surveillance, with surgery recommended for >5mm growth or lymph node metastasis, or 2) chosen to undergo immediate surgery. Medical records data will be collected, and questionnaires will be administered to both the active surveillance group and the immediate surgery/undecided group.


Eligibility

  • 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
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Where can I participate?

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

What is the full name of this clinical trial?

IIT2014-13-Ho-PMCAS: Active Surveillance of Papillary Thyroid Microcarcinoma

Study Details
Disease Type/Condition

Thyroid cancer

Principal Investigator

Ho, Allen

Co-Investigators

Beatrice Knudsen, Glenn Braunstein, Irene Chen, Jon Mallen-St. Clair, Michael D Harris, Michelle Melany, Pejman Cohan, Shikha Bose, Wendy Sacks

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

PRO00041265

ClinicalTrials.gov ID

NCT02609685

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Thyroid cancer

Principal Investigator

Ho, Allen

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

IIT2014-13-HO-PMCAS

ClinicalTrials.gov ID

NCT02609685

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org