Genetic Expression Alteration Affect on Lateral Neck Node Metastasis of Thyroid Papillary Microcarcinoma : Microarray Analysis - Full Text View

Purpose

In this study, the investigators look at the genetic expressional alteration which influenced on the early lateral neck node metastasis in thyroid papillary microcarcinoma.

Condition
Papillary Thyroid Microcarcinoma

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Genetic Expression Alteration Affect on Lateral Neck Node Metastasis of Thyroid Papillary Microcarcinoma : Microarray Analysis

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases

Drug Information available for: Thyroid

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

mRNA expression pattern by microarray analysis [ Time Frame: 24-hour after surgical removement ] [ Designated as safety issue: No ]
mRNA expression differences between papillary thyroid microcarcinoma without lateral neck node metastasis and the one with lateral neck node metastasis. (The outcome will be measured within 24-hour after surgical removement using papillary thyroid microcarcinoma tissue.)

Biospecimen Retention: Samples With DNA

mRNA extract from Thyroid tissue 2mmx2mmx2mm (nomal thyroid and papillary thyroid microcarcinoma >5mm)

Estimated Enrollment:	80
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Group 1 papillary thyroid microcarcinoma without lymph node metastasis
Group 2 papillary thyroid microcarcinoma with lateral lymph node metastasis

Detailed Description:

Papillary thyroid carcinomas (PTCs) measuring 1.0 cm or less in diameter were defined as papillary thyroid microcarcinomas (PTMCs) by the World Health Organization (WHO), emphasizing on their benign behavior, probably of little clinical significance, which do not affect patients' survival. However, some reported that PTMCs may have aggressive behavior, can cause locoregional recurrences, cervical lymph node metastases, and even distant metastases. But till now, the characteristics of PTMCs with early lateral neck node metastasis were only reviewed and described by the clinicopathological parameters, and no analysis of PTMCs by the gene level is available. In these study, we investigate the genetic expressional alteration which influenced on the early lateral neck node metastasis in thyroid papillary microcarcinoma.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients who were diagnosed as papillary thyroid microcarcinoma with or without lateral neck node metastasis

Criteria

Inclusion Criteria:

age≥20 years old
Conventional type papillary thyroid microcarcinoma (0.5cm≤tumor size≤1.0cm)
group 1: no lymph node metastasis /group 2: with lateral neck node metastasis

Exclusion Criteria:

tumor with capsular invasion (T3 tumor)
distant metastasis
combined underlying thyroiditis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384669

Locations

Korea, Republic of
Severance Hospital	Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woung-Youn Chung, MD, Ph.D 82-2-2228-2100 woungyounc@yuhs.ac
Contact: So-Hee Lee, MD 82-2-2228-2100 leesohee@yuhs.ac

Sponsors and Collaborators

Yonsei University

More Information

Publications:

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Responsible Party:	Woung-Youn Chung / Associate Professor, Department of General Surgery, Yonsei University Health System
ClinicalTrials.gov Identifier:	NCT01384669 History of Changes
Other Study ID Numbers:	4-2011-0212
Study First Received:	June 27, 2011
Last Updated:	June 28, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Neoplasm Metastasis
Thyroid Diseases
Neoplastic Processes

Neoplasms
Pathologic Processes
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013