PMCAS: Active Surveillance of Papillary Thyroid Microcarcinoma

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02609685
Collaborator
(none)
216
1
2
174.6
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Active Surveillance
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
216 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Active Surveillance of Papillary Thyroid Microcarcinoma
Actual Study Start Date :
May 13, 2016
Anticipated Primary Completion Date :
Dec 1, 2030
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

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

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of disease progression [From time of diagnosis up to10 years of follow-up]

Secondary Outcome Measures

  1. Percentage of subjects that will elect surgery despite absence of clinical progression [From time of diagnosis up to 10 years of follow-up]

  2. Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound [Five years]

  3. Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance [Five years]

  4. Identify the genetic factors associated with an increased risk of disease progression [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.

  5. Quality of life score as measured by City of Hope Quality of Life Scale [Up to five years]

  6. Anxiety score as measured by Memorial Anxiety Scale [Up to five years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center Los Angeles California United States 90048

Sponsors and Collaborators

  • Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Allen Ho, MD, Cedars-Sinal Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Allen Ho, Director, Head and Neck Cancer Program and Co-Director, Thyroid Cancer Program, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT02609685
Other Study ID Numbers:
  • IIT2014-13-Ho-PMCAS
First Posted:
Nov 20, 2015
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Keywords provided by Allen Ho, Director, Head and Neck Cancer Program and Co-Director, Thyroid Cancer Program, Cedars-Sinai Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022