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Active Surveillance of Papillary Thyroid Microcarcinoma (PMCAS)

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ClinicalTrials.gov Identifier: NCT02609685
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Allen Ho, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE May 13, 2016
Estimated Primary Completion Date December 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
Rate of disease progression [ Time Frame: From time of diagnosis up to10 years of follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • 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 ]
  • Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound [ Time Frame: Five years ]
  • Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance [ Time Frame: Five years ]
  • Identify the genetic factors associated with an increased risk of disease progression [ Time Frame: Five years ]
    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 [ Time Frame: Up to five years ]
  • Anxiety score as measured by Memorial Anxiety Scale [ Time Frame: Up to five years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Active Surveillance of Papillary Thyroid Microcarcinoma
Official Title  ICMJE Active Surveillance of Papillary Thyroid Microcarcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Papillary Thyroid Microcarcinoma
Intervention  ICMJE Other: Active Surveillance
Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Active Surveillance
  • No Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2015)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2030
Estimated Primary Completion Date December 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allen Ho, MD 310-423-1220 Allen.Ho@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609685
Other Study ID Numbers  ICMJE IIT2014-13-Ho-PMCAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allen Ho, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Allen Ho, MD Cedars-Sinal Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP