NCT02609685 Active Surveillance of Papillary Thyroid Microcarcinoma
| NCT ID | NCT02609685 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Papillary Thyroid Microcarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2016-05-13 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2016-05-13 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Allen Ho, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinal Medical Center
Frequently Asked Questions
Who can join the NCT02609685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Papillary Thyroid Microcarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02609685 currently recruiting?
Yes, NCT02609685 is actively recruiting participants. Contact the research team at Allen.Ho@cshs.org for enrollment information.
Where is the NCT02609685 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT02609685 clinical trial?
NCT02609685 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Allen Ho, MD at Cedars-Sinal Medical Center. The trial plans to enroll 216 participants.