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Active Surveillance of Papillary Thyroid Microcarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952612
Recruitment Status : Unknown
Verified November 2016 by Dong Jun Lim, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : November 2, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Dong Jun Lim, Seoul St. Mary's Hospital

Study Description
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Brief Summary:
Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this tumor are not palpable and are identified either through pathologic examination or from imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach. The purpose of this study is to understand more about the characteristics of papillary microcarcinoma, which has been known for "the cancer slowly progression"

Condition or disease
Thyroid Cancer, Papillary

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Active Surveillance of Papillary Thyroid Microcarcinoma (PTMC) in Catholic Medical Center
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Progression of papillary thyroid microcarcinoma [ Time Frame: 5 years after enrollment ]
    Using thyroid sonography, check any changes in size and shape of papillary thyroid microcarcinoma


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This observational study enrolls patients who was diagnosed as papillary thyroid microcarcinoma by FNA (Fine needle aspiration) or CNA(Core needle aspiration) and who wish to be enrolled this study.
Criteria

Inclusion Criteria:

  1. < 1 cm solitary nodule
  2. Surrounded by ≥ 2 mm normal thyroid parenchyma
  3. Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery
  4. No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
  5. No extrathyroidal extension
  6. Clinically N0 and Clinically M0
  7. ≥ 18 years
  8. Combined severe comorbidities or Inoperable condition (optional)
  9. No wish to surgery and Willingness to accept active surveillance
  10. No history of radiotherapy on head and neck area
  11. Accepted by the Board of Thyroid Cancer Meeting

Exclusion Criteria:

  1. ≥ 1 cm nodule and multifocal nodules regardless of size
  2. Papillary thyroid carcinoma variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant) or other types of thyroid cancer)
  3. Subcapsular locations adjacent to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
  4. Evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
  5. Extrathyroidal extension
  6. Any of N1 or M1
  7. Documented increase in size according to America Thyroid Association (ATA) guideline in a previously confirmed Papillary thyroid microcarcinoma
  8. < 18 years
  9. Not willing to accept observational active surveillance approach
Contacts and Locations
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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): NCT02952612


Contacts
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Contact: Jeonghoon Ha, MD +82-2-2258-6372 hajhoon@catholic.ac.kr
Contact: Kwanhoon Jo, MD +82-2-2258-1220 lovi@naver.com

Locations
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Korea, Republic of
Seoul St Mary's Hospital Recruiting
Seoul, Seocho-Gu, Korea, Republic of, 137-701
Contact: Dong Jun Lim, MD,PhD    +82-2-2258-1220    ldj6026@catholic.ac.kr   
Contact: Kwanhoon Jo, MD    82-2-2258-1220    lovi@naver.com   
Sub-Investigator: Jeonghoon Ha, MD         
Sub-Investigator: Kwanhoon Jo, MD         
Sub-Investigator: Jeongmin Lee, MD         
Sponsors and Collaborators
Dong Jun Lim
Investigators
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Study Chair: Dong-Jun Lim, MD, PhD Seoul St. Mary's Hospital
More Information
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Responsible Party: Dong Jun Lim, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02952612    
Other Study ID Numbers: KC16OISI0414
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma, Papillary
Adenocarcinoma