Clinical trial NCT02814032: Proteomics of Papillary Thyroid Carcinoma
Official title: Differences Protein Expression in Papillary Thyroid Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Papillary Thyroid Carcinoma
Keywords: proteomic
cervical lymph node metastasis
Lead sponsor: The Affiliated Hospital of Inner Mongolia Medical University
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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 ).

Eligibility criteria: 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).

Primary outcomes:
measure: differences in protein expression
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Shan Jin
state: Inner Mongolia
Study officials:
affiliation: The Affiliated Hospital of Inner Mongolia Medical University
name: Shan Jin, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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