Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT03271892
Eligibility Criteria:
Inclusion Criteria:
1. Patients 18 years of age or older
2. Newly diagnosed previously untreated papillary thyroid cancer (PTC) (fine needle aspiration biopsy positive for PTC or suspicious for PTC).
3. PTC must be less than 2 cm in maximal diameter on thyroid ultrasound
4. No evidence of metastatic cervical lymphadenopathy on ultrasound imaging of the neck (or other neck imaging) and no known distant metastatic thyroid cancer.
5. No other absolute indications for thyroid or parathyroid surgery
6. Permission for review of thyroid cancer-related medical records
Exclusion Criteria:
1. Regional or distant metastatic thyroid cancer
2. History of prior thyroid cancer surgery
3. High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea)
4. The patient has clinical signs, imaging, or indirect laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the strap muscles of the neck, trachea or esophagus)
5. Known or suspected poorly differentiated or non-papillary thyroid cancer
6. Medically unfit for surgery due to co-morbidity
7. Another active malignancy with limited life expectancy of \< 1 year.
8. Pregnancy at the time of study enrollment.
9. Other absolute indication for thyroid or parathyroid surgery
10. Unable to provide informed consent for the study or comply with study follow-up procedures due to current severe active cognitive or psychiatric impairment, substance abuse, or other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03271892
Study Brief:
Protocol Section:
NCT03271892