Clinical trial NCT02609685: Active Surveillance of Papillary Thyroid Microcarcinoma
Official title: Active Surveillance of Papillary Thyroid Microcarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Papillary Thyroid Microcarcinoma
Keywords: Thyroid cancer
Active surveillance
PTMC
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of disease progression
timeFrame: From time of diagnosis up to10 years of follow-up
Secondary outcomes:
measure: Percentage of subjects that will elect surgery despite absence of clinical progression
timeFrame: From time of diagnosis up to 10 years of follow-up
measure: Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound
timeFrame: Five years
measure: Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance
timeFrame: Five years
measure: Identify the genetic factors associated with an increased risk of disease progression
timeFrame: Five years
measure: Quality of life score as measured by City of Hope Quality of Life Scale
timeFrame: Up to five years
measure: Anxiety score as measured by Memorial Anxiety Scale
timeFrame: Up to five years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinal Medical Center
name: Allen Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ho AS, Kim S, Zalt C, Melany ML, Chen IE, Vasquez J, Mallen-St Clair J, Chen MM, Vasquez M, Fan X, van Deen WK, Haile RW, Daskivich TJ, Zumsteg ZS, Braunstein GD, Sacks WL. Expanded Parameters in Active Surveillance for Low-risk Papillary Thyroid Carcinoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2022 Sep 15;8(11):1588-96. doi: 10.1001/jamaoncol.2022.3875. Online ahead of print.