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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02814032
Other study ID # AHInnerMongolia-Thyroid-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2016
Est. completion date June 2024

Study information

Verified date July 2023
Source The Affiliated Hospital of Inner Mongolia Medical University
Contact Shan Jin, PhD
Phone +86-15849338280
Email jinshangood@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become the malignant neoplasm of fastest growing incidence rate. More than 85% thyroid carcinoma is papillary thyroid carcinoma. Cervical lymph node metastasis is common in papillary thyroid carcinoma patients. This study aim to reveal protein expression differences between papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis.


Description:

1. Object: Patients aged 18-65 years; newly diagnosed papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer. 2. Clinical information, examination data: Information is obtained from medical record abstraction. 3. Samples: Fresh frozen thyroid tissues from each sample group(normal histology, benign disease, papillary thyroid carcinoma with cervical lymph node metastasis, papillary thyroid carcinoma without cervical lymph node metastasis ).


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date June 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Newly diagnosed papillary thyroid carcinoma. - Undergo thyroidectomy according to the China thyroid association guidelines forthe Management of thyroid nodule and thyroid cancer. Exclusion Criteria: - Current substance abuse/dependence. - Daily tobacco and alcohol use. - Whole neck irradiation or surgery. - Prior cancer diagnosis or chemotherapy treatment. - Active autoimmune disorder. - Uncontrolled allergic condition or asthma. - Chronic use of oral steroid medication. - Hormone therapy (estrogen, progestin compounds).

Study Design


Locations

Country Name City State
China Shan Jin Hohhot Inner Mongolia

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of Inner Mongolia Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Brown LM, Helmke SM, Hunsucker SW, Netea-Maier RT, Chiang SA, Heinz DE, Shroyer KR, Duncan MW, Haugen BR. Quantitative and qualitative differences in protein expression between papillary thyroid carcinoma and normal thyroid tissue. Mol Carcinog. 2006 Aug;45(8):613-26. doi: 10.1002/mc.20193. — View Citation

Gharib H, Papini E. Thyroid nodules: clinical importance, assessment, and treatment. Endocrinol Metab Clin North Am. 2007 Sep;36(3):707-35, vi. doi: 10.1016/j.ecl.2007.04.009. — View Citation

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. — View Citation

Sofiadis A, Becker S, Hellman U, Hultin-Rosenberg L, Dinets A, Hulchiy M, Zedenius J, Wallin G, Foukakis T, Hoog A, Auer G, Lehtio J, Larsson C. Proteomic profiling of follicular and papillary thyroid tumors. Eur J Endocrinol. 2012 Apr;166(4):657-67. doi: 10.1530/EJE-11-0856. Epub 2012 Jan 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary differences in protein expression 6 months
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