Optimal Measurement of Thyroglobulin Measurement Following Thyroidectomy

NCT02347683 | Completed

• 1 other identifier: 0594-14-FB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal timing to measure thyroglobulin(Tg) after thyroidectomy is unknown in patients with thyroid cancer. The ATA and NCCN guidelines are not specific on optimal timing of Tg levels in post-op state and suggest anywhere between 2-12 weeks. Hypothesis - Post -op Tg nadirs at 6-8 weeks . Primary Objective -Determine optimal timing of post thyroidectomy Tg nadir, so to determine the most accurate time to check post operatively. Secondary Outcome - Determine factors that will affect Tg levels post operatively. All adults age 19 and above already planning to undergo near total /total thyroidectomy for reasons unrelated to the study. Measure Tg , Tg Ab and TSH pre-op, post op ---\> 7-14 days, 4 wk, 6 wk, and 3 month in patients with pathology confirmed benign disease. Measure Tg , Tg Ab , TSH pre-op, post op ---\> 7-14 days, 4 wk, 6 wk, 3 month, 6 month, and 12 month in patients with thyroid cancer.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Optimal timing of post thyroidectomy thyroglobulin (Tg) nadir

  Determine optimal timing of post thyroidectomy thyroglobulin (Tg) nadir, so to determine the most accurate time to check post operatively.

  within a year

Secondary Outcomes (1)

• Factors affecting thyroglobulin (Tg) levels post operatively

  within a year

Study Arms (2)

Benign pathology

We will measure serum Tg , Tg Ab levels , and TSH at 7-14 days, 4, 6, and 12 weeks

Malignant pathology

We will measure serum Tg , Tg Ab levels , and TSH at 7-14 days ; 4, 6, and 12 weeks and 6 and 12 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adults age 19 and above already planning to undergo near total /total thyroidectomy for reasons unrelated to the study.

You may qualify if:

• All patients already planning to undergo total /near total thyroidectomy for reasons unrelated to this study.
• Age 19 or older

You may not qualify if:

• Children \< 19 years
• Pregnancy

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• Patel A, Shostrom V, Treude K, Lydiatt W, Smith R, Goldner W. Serum Thyroglobulin: Preoperative Levels and Factors Affecting Postoperative Optimal Timing following Total Thyroidectomy. Int J Endocrinol. 2019 Feb 20;2019:1384651. doi: 10.1155/2019/1384651. eCollection 2019.

  PMID: 30915112 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Whitney Goldner, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

US (1)