Thyroid Nodule Clinical Trials

Find Thyroid Nodule Clinical Trials Near You

Active Surveillance of Papillary Thyroid Microcarcinoma

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Allen Ho, MD
Allen.Ho@cshs.org
310-423-1220
Time Frame
Start Date: 2016-05-13
Estimated Completion Date: 2030-12
Participants
Target number of participants: 216
Treatments
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.
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.
Sponsors
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov