Active Surveillance of Papillary Thyroid Microcarcinoma
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ClinicalTrials.gov Identifier: NCT02952612 |
Recruitment Status :
Recruiting
First Posted : November 2, 2016
Last Update Posted : November 8, 2016
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Condition or disease |
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Thyroid Cancer, Papillary |
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 |

- 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

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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 |
Inclusion Criteria:
- < 1 cm solitary nodule
- Surrounded by ≥ 2 mm normal thyroid parenchyma
- Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery
- No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- No extrathyroidal extension
- Clinically N0 and Clinically M0
- ≥ 18 years
- Combined severe comorbidities or Inoperable condition (optional)
- No wish to surgery and Willingness to accept active surveillance
- No history of radiotherapy on head and neck area
- Accepted by the Board of Thyroid Cancer Meeting
Exclusion Criteria:
- ≥ 1 cm nodule and multifocal nodules regardless of size
- Papillary thyroid carcinoma variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant) or other types of thyroid cancer)
- Subcapsular locations adjacent to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- Evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- Extrathyroidal extension
- Any of N1 or M1
- Documented increase in size according to America Thyroid Association (ATA) guideline in a previously confirmed Papillary thyroid microcarcinoma
- < 18 years
- Not willing to accept observational active surveillance approach

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
Contact: Jeonghoon Ha, MD | +82-2-2258-6372 | hajhoon@catholic.ac.kr | |
Contact: Kwanhoon Jo, MD | +82-2-2258-1220 | lovi@naver.com |
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 |
Study Chair: | Dong-Jun Lim, MD, PhD | Seoul St. Mary's Hospital |
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 |
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 |