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 2013
Estimated Primary Completion Date:	December 2013 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Korea, Republic of
Severance Hospital	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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Chow SM, Law SC, Chan JK, Au SK, Yau S, Lau WH. Papillary microcarcinoma of the thyroid-Prognostic significance of lymph node metastasis and multifocality. Cancer. 2003 Jul 1;98(1):31-40.

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Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01384669 History of Changes
Other Study ID Numbers:	4-2011-0212
Study First Received:	June 27, 2011
Last Updated:	June 1, 2013
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:


Thyroid Diseases Carcinoma, Papillary Thyroid Neoplasms Endocrine System Diseases Carcinoma Neoplasms, Glandular and Epithelial	Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 29, 2016