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

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ClinicalTrials.gov Identifier: NCT01384669
Recruitment Status : Unknown
Verified June 2013 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : June 29, 2011
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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 or disease
Papillary Thyroid Microcarcinoma

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.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Expression Alteration Affect on Lateral Neck Node Metastasis of Thyroid Papillary Microcarcinoma : Microarray Analysis
Study Start Date : June 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

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



Primary Outcome Measures :
  1. mRNA expression pattern by microarray analysis [ Time Frame: 24-hour after surgical removement ]
    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)


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01384669     History of Changes
Other Study ID Numbers: 4-2011-0212
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

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