Correlation Between TCM Syndrome Factors and TSH Changes of Thyroid Hormone Withdrawal Before Iodine Therapy in Postoperative Patients With Thyroid Cancer

NCT04916262 | Unknown

• 1 other identifier: LJB-02
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to make a dialectical classification of patients who will receive 131I treatment after operation of thyroid cancer from the point of view of dialectics of syndrome elements of traditional Chinese medicine. By observing the changes of TSH among patients with different syndrome types, investigators can better understand the reasons for the differences in TSH changes among patients. Thus, it provides a basis for putting forward the scheme of stopping taking levothyroxine before iodine treatment, improving the quality of life of patients after radical thyroidectomy, and providing reference for individualized guidance of the timing of radioactive iodine therapy for patients after DTC.

Conditions

Differentiated Thyroid Carcinoma; TCM Syndrome Type

Keywords

Differentiated Thyroid Carcinoma; TCM syndrome type

Outcome Measures

Primary Outcomes (2)

• Primary Outcome Measure 1

  The TCM syndrome types of patients participating in this study were evaluated by TCM syndrome factor scale, and the diagnosis was established when the total weight of the scale was more than 20

  The data will be collected, analyzed and calculated in about 3 days.

• Primary Outcome Measure 2

  Correlation analysis was used to analyze the correlation between TCM syndrome types and the time needed for thyrotropin ≥ 30uIU/ml during the treatment of thyroid hormone withdrawal.

  The data will be collected, analyzed and calculated in about 3 days.

Secondary Outcomes (8)

• Secondary Outcome Measure 1

  2 weeks.

• Secondary Outcome Measure 2

  2 weeks.

• Secondary Outcome Measure 3

  2 weeks.

• Secondary Outcome Measure 4

  2 weeks.

• Secondary Outcome Measure 5

  2 weeks.

Study Arms (2)

TSH < 30uIU/mL group

Clinical information was collected from patients with TSH \< 30UIU /mL on the 14th day of thyroxine withdrawal before 131I treatment，including TCM syndrome elements, general information ,medical history and biochemical examination during hospitalization.

TSH ≥ 30uIU/mL group

Clinical information was collected from patients with TSH ≥ 30UIU /mL on the 14th day of thyroxine withdrawal before 131I treatment，including TCM syndrome elements, general information ,medical history and biochemical examination during hospitalization.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with thyroid cancer who need 131I therapy after operation

You may qualify if:

• Study time: June 1, 2021, to January 1, 2022;
• Study site: The First Affiliated Hospital of Shandong First Medical University;
• years old (including upper and lower limits), male or female;
• Patients with differentiated thyroid carcinoma diagnosed pathologically after total thyroidectomy
• Patients with oral levothyroxine tablets ≥ 4 weeks after operation
• Patients who have stopped taking levothyroxine tablets and whose TSH \< 4.2uIU/ml at the time of withdrawal
• Patients who meet the 131I treatment criteria

You may not qualify if:

• Pregnant or lactating women
• Patients with various mental disorders, unconscious, etc.
• Cases with inaccurate information collection

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Related Publications (4)

• Zhou Y, Yang Y, Zhou T, Li B, Wang Z. Adiponectin and Thyroid Cancer: Insight into the Association between Adiponectin and Obesity. Aging Dis. 2021 Apr 1;12(2):597-613. doi: 10.14336/AD.2020.0919. eCollection 2021 Apr.

  PMID: 33815885 BACKGROUND

• Stewart LA, Kuo JH. Advancements in the treatment of differentiated thyroid cancer. Ther Adv Endocrinol Metab. 2021 Mar 17;12:20420188211000251. doi: 10.1177/20420188211000251. eCollection 2021.

  PMID: 33796254 BACKGROUND

• Borges de Souza P, McCabe CJ. Radioiodine treatment: an historical and future perspective. Endocr Relat Cancer. 2021 Sep 3;28(10):T121-T124. doi: 10.1530/ERC-21-0037. No abstract available.

  PMID: 33690155 BACKGROUND

• Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.

  PMID: 26462967 BACKGROUND

Study Officials

• Lin Liao, Doctor

  The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Liao, Doctor

CONTACT

18354117713; liaolin@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 7, 2021
• Study Start: June 20, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 16, 2021

Record last verified: 2021-06