Thyroid Cancer
Conditions
Keywords
thyroid cancer, thyroid nodule, thyroidectomy, personalized medicine
Brief summary
The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.
Detailed description
The aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. This study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.
Interventions
PROCEDUREThyroid lobectomy
Thyroid lobectomy is removal of only part of the thyroid
PROCEDURETotal thyroidectomy with CCND
Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes
Sponsors
University of Pittsburgh
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Thyroid nodule is \>1.5 cm * Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer
Exclusion criteria
* Prior thyroid/parathyroid surgery * Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when \<18 years old * Recurrent laryngeal nerve dysfunction * Diagnosis of concurrent primary hyperparathyroidism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who require completion thyroidectomy for aggressive histology features | 2 years | Histology characteristics of tumor will be assessed including type of cancer, extrathyroidal extension, lymph node metastasis, and margin status to assess if completion thyroidectomy is needed per the 2015 ATA guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with operative complications | 2 years | incidence of permanent nerve injury, hypocalcemia, readmission |
| Recurrence | >2 years | — |
| Number of patients who had central compartment neck dissection but no lymph node metastasis were identified | 2 years | — |
| QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup | 2 years | — |
| QOL metric - SF36 cumulative score preop, postop, and at followup | 2 years | — |
| QOL metric - FACT-G cumulative score preop, postop, and at followup | 2 years | — |
Countries
United States
Outcome results
None listed