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Active Surveillance on Papillary Thyroid Microcarcinoma

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ClinicalTrials.gov Identifier: NCT02938702
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Young Joo Park, Seoul National University Hospital

Brief Summary:
The study is a multi-center prospective cohort study of active surveillance in papillary thyroid cancer with low risk. The purpose of the study is to observe natural course of low risk papillary thyroid cancer in Korean population, and comparison of prognosis between active surveillance group and conventional surgery group. Patient will be well informed about their choice of active surveillance or surgery.

Condition or disease
Thyroid Cancer Papillary Thyroid Microcarcinoma

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : May 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Group/Cohort
Active surveillance
Group with active surveillance of their PTC
Surgery
Group who underwent surgery after diagnosis of PTC



Primary Outcome Measures :
  1. Rate of Progression of Thyroid Papillary Microcarcinoma [ Time Frame: 5 years ]
    rate of progression: whether tumor size increases more than 3 mm in diameter, or tumor involves new lymph nodes, or metastasis occurs


Secondary Outcome Measures :
  1. Comparison of Progression Rate between Active Surveillance and Surgery Group [ Time Frame: 5 years ]
    Which group had higher progression rate; progression defined as whether tumor size increases more than 3 mm in diameter, or tumor involves new lymph nodes, or metastasis occurs



Information from the National Library of Medicine

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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:   Probability Sample
Study Population
Patient aged older than 18 years with papillary thyroid microcarcinoma less than 1 cm in length, who did not meet the exclusion criteria from Seoul National University Hospital, National Cancer Center, Seoul National University Bundang Hospital, and Borame Medical Center.
Criteria

Inclusion Criteria:

  • who agreed to the agreement form
  • who is older than 18 years old
  • who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category V or VI
  • whose thyroid cancer is smaller than 1 cm length

Exclusion Criteria:

  • who cannot routinely follow-up according to the study schedule
  • who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category I, II, III, or IV.
  • who have hyperthyroidism which needs treatment

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): NCT02938702


Contacts
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Contact: Young Joo Park, MD, Ph.D. +82-2-2072-4183

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young Joo Park, MD, Ph.D.    +82-2072-4183      
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Young Joo Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02938702     History of Changes
Other Study ID Numbers: 2520160010
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Young Joo Park, Seoul National University Hospital:
Active surveillance

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