Active Surveillance of Papillary Thyroid Microcarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-13

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Papillary Thyroid Microcarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Active Surveillance

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active Surveillance

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No