Active Surveillance of Papillary Thyroid Microcarcinoma

Papillary Thyroid Microcarcinoma Clinical Trial

— PMCAS  

Official title:

Active Surveillance of Papillary Thyroid Microcarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02609685
• Other study ID #: IIT2014-13-Ho-PMCAS
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2016
• Est. completion date: December 2030

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Allen Ho, MD
• Phone: 310-423-1220
• Email: Allen.Ho[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papillary Thyroid Microcarcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of disease progression		From time of diagnosis up to10 years of follow-up
Secondary	Percentage of subjects that will elect surgery despite absence of clinical progression		From time of diagnosis up to 10 years of follow-up
Secondary	Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound		Five years
Secondary	Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance		Five years
Secondary	Identify the genetic factors associated with an increased risk of disease progression	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
Secondary	Quality of life score as measured by City of Hope Quality of Life Scale		Up to five years
Secondary	Anxiety score as measured by Memorial Anxiety Scale		Up to five years