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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk | Experimental | Molecular testing and ultrasound features will be used to predict if thyroid cancer is low risk. Intervention will be to perform thyroid lobectomy. |
|
| High Risk | Experimental | Molecular testing and ultrasound features will be used to predict if thyroid cancer is high risk. Intervention will be to perform more aggressive surgery to include total thyroidectomy with CCND. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thyroid lobectomy | Procedure | Thyroid lobectomy is removal of only part of the thyroid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who require completion thyroidectomy for aggressive histology features | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who had central compartment neck dissection but no lymph node metastasis were identified | 2 years | |
| Number of patients with operative complications | incidence of permanent nerve injury, hypocalcemia, readmission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linwah Yip, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States | ||
| Medical College of Wisconsin |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D056741 | Cyclin D |
| ID | Term |
|---|---|
| D016213 | Cyclins |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Total thyroidectomy with CCND |
| Procedure |
Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes |
|
| 2 years |
| Recurrence | >2 years |
| QOL metric - FACT-G cumulative score preop, postop, and at followup | 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 |
| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D018797 | Cell Cycle Proteins |
| D011506 | Proteins |