Optimal Measurement of Thyroglobulin Measurement Following Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Optimal timing of post thyroidectomy thyroglobulin (Tg) nadir
研究概览
简要总结
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.
详细描述
Thyroid cancer, the most common endocrine tumor, constitutes 3.8% of all cancers. 62,980 new cases were estimated in the U.S. in 20141, an increasing trend from the 37,200 new cases in 20092. 90% of all thyroid cancers are differentiated thyroid carcinomas (DTC), which include both papillary and follicular thyroid carcinoma3.
Management of DTC involves a total thyroidectomy, with possible central and lateral neck dissection if there are clinical lymph node involvement, except for low-risk lesions that are unifocal, intrathyroidal, node-negative and measuring less than 1 cm in size. Radioactive iodine ablation of any remnant thyroid tissue may follow a total thyroidectomy depending on the risk stratification of the patient3. As for any cancer, management of thyroid cancer involves long-term surveillance for early detection of disease recurrence3.
According to the ATA guidelines, postoperative surveillance includes regular (every 6 to 12 months) clinical evaluation for tumor recurrence, evaluation with neck ultrasound and serum Thyroglobulin (Tg) levels while on levothyroxine replacement3. Serum Tg has become a very useful and well-acknowledged marker in patients with thyroid cancer post thyroidectomy for disease persistence, metastasis or recurrence.
Thyroglobulin is a 660 kDa dimeric glycoprotein that is exclusively produced and stored by thyroid follicular cells in benign conditions, but also by well-differentiated thyroid cancer cells4. A total thyroidectomy for higher risk patients is thus not only is important to provide definitive treatment and decrease risk of recurrence, but also allows for long term follow-up with Tg levels.
One study has reported Tg is eliminated through the liver and its half-life following total thyroidectomy has been reported to be about 65.2 hours. The Tg level was noted to decrease to less than 5-10 ng/ml 25 days after thyroidectomy, or after 7 to 10 half-lives in 11 patient samples5. Detection of Tg following the total thyroidectomy during long-term surveillance would therefore suggest persistent thyroid tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients already planning to undergo total /near total thyroidectomy for reasons unrelated to this study.
- •Age 19 or older
排除标准
- •Children < 19 years
结局指标
主要结局
Optimal timing of post thyroidectomy thyroglobulin (Tg) nadir
时间窗: within a year
Determine optimal timing of post thyroidectomy thyroglobulin (Tg) nadir, so to determine the most accurate time to check post operatively.
次要结局
- Factors affecting thyroglobulin (Tg) levels post operatively(within a year)