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Active Surveillance of Papillary Thyroid Microcarcinoma (PMCAS)

Primary Purpose

Papillary Thyroid Microcarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Surveillance
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Papillary Thyroid Microcarcinoma focused on measuring Thyroid cancer, Active surveillance, PTMC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Active Surveillance

Immediate Surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of disease progression

Secondary Outcome Measures

Percentage of subjects that will elect surgery despite absence of clinical progression
Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound
Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance
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.
Quality of life score as measured by City of Hope Quality of Life Scale
Anxiety score as measured by Memorial Anxiety Scale

Full Information

First Posted
November 18, 2015
Last Updated
October 3, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02609685
Brief Title
Active Surveillance of Papillary Thyroid Microcarcinoma
Acronym
PMCAS
Official Title
Active Surveillance of Papillary Thyroid Microcarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2016 (Actual)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Microcarcinoma
Keywords
Thyroid cancer, Active surveillance, PTMC

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Surveillance
Arm Type
Other
Arm Description
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.
Arm Title
Immediate Surgery
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active Surveillance
Intervention Description
Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.
Primary Outcome Measure Information:
Title
Rate of disease progression
Time Frame
From time of diagnosis up to10 years of follow-up
Secondary Outcome Measure Information:
Title
Percentage of subjects that will elect surgery despite absence of clinical progression
Time Frame
From time of diagnosis up to 10 years of follow-up
Title
Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound
Time Frame
Five years
Title
Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance
Time Frame
Five years
Title
Identify the genetic factors associated with an increased risk of disease progression
Description
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.
Time Frame
Five years
Title
Quality of life score as measured by City of Hope Quality of Life Scale
Time Frame
Up to five years
Title
Anxiety score as measured by Memorial Anxiety Scale
Time Frame
Up to five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allen Ho, MD
Phone
310-423-1220
Email
Allen.Ho@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Ho, MD
Organizational Affiliation
Cedars-Sinal Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allen Ho, MD
Phone
310-423-1220
Email
Allen.Ho@cshs.org
First Name & Middle Initial & Last Name & Degree
Allen Ho, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
36107411
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.
Results Reference
derived

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Active Surveillance of Papillary Thyroid Microcarcinoma

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