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Trial record 1 of 1 for:    Linwah Yip
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Molecular Testing to Direct Extent of Initial Thyroid Surgery

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Linwah Yip, University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Linwah Yip, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02947035
First received: October 20, 2016
Last updated: November 16, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Thyroid Cancer Procedure: Thyroid lobectomy Procedure: Total thyroidectomy with CCND Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Molecular Testing to Direct Extent of Initial Thyroid Surgery

Resource links provided by NLM:


Further study details as provided by Linwah Yip, University of Pittsburgh:

Primary Outcome Measures:
  • Number of patients who require completion thyroidectomy for aggressive histology features [ Time Frame: 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 Outcome Measures:
  • Number of patients who had central compartment neck dissection but no lymph node metastasis were identified [ Time Frame: 2 years ]
  • Number of patients with operative complications [ Time Frame: 2 years ]
    incidence of permanent nerve injury, hypocalcemia, readmission

  • Recurrence [ Time Frame: >2 years ]
  • QOL metric - FACT-G cumulative score preop, postop, and at followup [ Time Frame: 2 years ]
  • QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup [ Time Frame: 2 years ]
  • QOL metric - SF36 cumulative score preop, postop, and at followup [ Time Frame: 2 years ]

Estimated Enrollment: 90
Study Start Date: November 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Risk
Molecular testing and ultrasound features will be used to predict if thyroid cancer is low risk. Intervention will be to perform thyroid lobectomy.
Procedure: Thyroid lobectomy
Thyroid lobectomy is removal of only part of the thyroid
Experimental: High Risk
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.
Procedure: Total thyroidectomy with CCND
Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02947035

Contacts
Contact: Linwah Yip, MD 412-647-0467 yipl@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Linwah Yip, MD    412-647-0467    yipl@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Linwah Yip, MD University of Pittsburgh
  More Information

Responsible Party: Linwah Yip, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02947035     History of Changes
Other Study ID Numbers: PRO15010023
Study First Received: October 20, 2016
Last Updated: November 16, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Linwah Yip, University of Pittsburgh:
thyroid cancer
thyroid nodule
thyroidectomy
personalized medicine

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on August 17, 2017