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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01384669
First received: June 27, 2011
Last updated: June 1, 2013
Last verified: June 2013
  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:


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
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:

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 18, 2014