Monitoring small thyroid cancers without immediate surgery
Active Surveillance of Papillary Thyroid Microcarcinoma
NA · Cedars-Sinai Medical Center · NCT02609685
This study tests whether watching small thyroid cancers closely instead of doing surgery right away is a safe option for patients and looks at how this choice affects their quality of life and anxiety.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT02609685 on ClinicalTrials.gov |
What this trial studies
This study investigates the outcomes of active surveillance for patients with papillary thyroid microcarcinoma (PTMC) instead of the standard immediate surgical intervention. It aims to estimate the rate of disease progression over 3, 5, and 10 years in patients with thyroid nodules measuring 1.5 cm or smaller. Participants can choose to undergo surgery at any time if deemed necessary by them and their physician. Additionally, a sub-study will assess quality of life and anxiety levels in patients opting for surgery compared to those in active surveillance.
Who should consider this trial
Good fit: Ideal candidates are individuals with pathologically confirmed small papillary thyroid carcinoma nodules and no signs of aggressive disease.
Not a fit: Patients with high-grade thyroid cancer variants or those with suspicious lymphadenopathy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary surgeries and associated complications for patients with low-risk thyroid cancers.
How similar studies have performed: Previous studies on active surveillance for low-risk thyroid cancers have shown promising results, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Allen Ho, MD — Cedars-Sinal Medical Center
- Study coordinator: Allen Ho, MD
- Email: Allen.Ho@cshs.org
- Phone: 310-423-1220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Papillary Thyroid Microcarcinoma, Thyroid cancer, Active surveillance, PTMC