Background: - Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard to detect. People often have lymph nodes removed anyway, and researchers want to study if this is a good idea. Objective: - To compare the effectiveness of removing lymph nodes in the neck that show no evidence of cancer along with the thyroid, or removing only the thyroid. Eligibility: - Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence that the disease has spread in the body. Design: - Participants will be screened with medical history, physical exam, blood tests, scans, and x-rays. - Participants will: - Answer questions. They may have a tumor biopsy. - Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal cords. - Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be removed if the cancer has spread. - Group 2: have surgery to remove the thyroid and lymph nodes in the neck. - At all post-surgery visits, participants will answer questions and have blood drawn. In addition: - 1 day: laryngoscopy. - 2 weeks: possible laryngoscopy. - 3 months: ultrasound of the thyroid and neck. - Discuss whether to try hormone treatment and/or radioactive iodine. - Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a capsule or liquid and lie under a camera. - 6 months: ultrasound and maybe laryngoscopy. - 1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone. - Participants will have annual follow-up visits for 10 years. They will have a physical exam, blood drawn, scans, and may complete a questionnaire.
Name: Total Thyroidectomy (TT)
Description: Total removal of thyroidType: Procedure1 2
Name: Prophylactic central neck lymph node dissection(pCND)
Description: Lymph node dissectionType: Procedure1
Description: Proportion of patients that have biochemical cure after totalthyroidectomy (TT) with and without pCND
Measure: Biochemical cure rates undergoing total thyroidectomy (TT) with and without pCND as measured by postoperative TSH-stimulated serum thyroglobulin (stim-Tg) at 3 months (prior to RAI treatment) Time: 3 monthsDescription: Proportion of patients that have biochemical cure after TT with andwithout pCND
Measure: Biochemical cure rates in patients undergoing total thyroidectomy with and without pCND by postoperative TSH-stimulated serum thyroglobulin (stim-Tg) at 1 year postoperatively in patients who will not receive RAI or 1 year post remnant ablation Time: 1 yearDescription: Proportion of patients that have improvement in quality of life afterTT with and without pCND
Measure: The QOL of patients Time: 10 yearsDescription: Proportion of patients that have improvement in voice quality,swallowing impairment after TT with and without pCND
Measure: Subjective voice quality, swallowing impairment Time: 6 monthDescription: Rate and duration hypoparathyroidism
Measure: Rate and duration of both symptomatic and asymptomatic hypoparathyroidism Time: 6 monthDescription: Proportion of patients that have cervical wound complications
Measure: Rate of cervical wound complications Time: 3 monthDescription: Correlation between BRAF V600E of tumor and median amount of time before disease progression
Measure: Correlation between BRAF V600E of tumor and median amount of time before disease progression Time: at progressionDescription: Proportion of patients that have less neck pain
Measure: Neck pain Time: 6 monthAllocation: Randomized
Parallel Assignment
There is one SNP
Correlation between BRAF V600E of tumor and median amount of time before disease progression. --- V600E ---
but less than or equal to 4 cm measured in greatest dimension and confirmed by the Laboratory of Pathology, NCI or confirmed by the pathology laboratory of the enrolling institution: - Indeterminate thyroid biopsy per Bethesda System for reporting thyroid cytopathology with BRAF V600E mutation or RET/PTC rearrangement - Cytologically or histologically suspicious or confirmed PTC per Bethesda System for reporting thyroid cytopathology. --- V600E ---
but less than or equal to 4 cm. in size with either: - inconclusive thyroid cytology positive for BRAF V600E mutation or RET/PTC rearrangement or - cytologically suspicious for or consistent with PTC - Absence of extrathyroidal extension or lymphadenopathy suggesting metastatic PTC on physical examination and neck ultrasound. --- V600E ---