What this study is
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.
What's being tested
- Active Surveillance
Intervention · OTHER
Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.
Study details
- Sponsor
- Cedars-Sinai Medical Center
- Conditions
- Papillary Thyroid Microcarcinoma
- Enrolling
- 216 people
- Starts
- 2016-05-13
- Est. completion
- 2030-12
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCedars-Sinai Medical Center
Los Angeles, California, United States
- Allen Ho, MD · Contact310-423-1220Allen.Ho@cshs.org
- Allen Ho, MD · Principal investigator
Recruiting
Study team
Sponsor
Cedars-Sinai Medical Center
Study ID IIT2014-13-Ho-PMCAS
Principal investigator
Allen Ho, MD
Cedars-Sinal Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.