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Active Surveillance of Papillary Thyroid Microcarcinoma (PMCAS)

This study is currently recruiting participants.
Verified September 2016 by Allen Ho, Cedars-Sinai Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02609685
First Posted: November 20, 2015
Last Update Posted: September 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Allen Ho, Cedars-Sinai Medical Center
  Purpose
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 Intervention
Papillary Thyroid Microcarcinoma Other: Active Surveillance

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Active Surveillance of Papillary Thyroid Microcarcinoma

Resource links provided by NLM:


Further study details as provided by Allen Ho, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Rate of disease progression [ Time Frame: From time of diagnosis up to10 years of follow-up ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 216
Study Start Date: December 2015
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2030 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma
  • 1.5 cm or smaller nodules by ultrasonographic criteria
  • Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609685


Contacts
Contact: Allen Ho, MD 310-423-1220 Allen.Ho@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Allen Ho, MD    310-423-1220    Allen.Ho@cshs.org   
Principal Investigator: Allen Ho, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Allen Ho, MD Cedars-Sinal Medical Center
  More Information

Responsible Party: Allen Ho, Director, Head and Neck Cancer Program and Co-Director, Thyroid Cancer Program, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02609685     History of Changes
Other Study ID Numbers: IIT2014-13-Ho-PMCAS
First Submitted: November 18, 2015
First Posted: November 20, 2015
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Allen Ho, Cedars-Sinai Medical Center:
Thyroid cancer
Active surveillance
PTMC

Additional relevant MeSH terms:
Thyroid Diseases
Carcinoma, Papillary
Thyroid Neoplasms
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms