Active Surveillance of Papillary Thyroid Microcarcinoma (PMCAS)
|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.|
|ClinicalTrials.gov Identifier: NCT02609685|
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Papillary Thyroid Microcarcinoma||Other: Active Surveillance||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Active Surveillance of Papillary Thyroid Microcarcinoma|
|Actual Study Start Date :||May 13, 2016|
|Estimated Primary Completion Date :||December 2030|
|Estimated Study Completion Date :||December 2030|
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.
- Rate of disease progression [ Time Frame: From time of diagnosis up to10 years of follow-up ]
- 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 ]
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
|Contact: Allen Ho, MD||310-423-1220||Allen.Ho@cshs.org|
|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|
|Principal Investigator:||Allen Ho, MD||Cedars-Sinal Medical Center|