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Active Surveillance of Papillary Thyroid Microcarcinoma

NCT ID: NCT02952612

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2021-10-31

Brief Summary

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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"

Detailed Description

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Conditions

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Thyroid Cancer, Papillary

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong Jun Lim

OTHER

Sponsor Role lead

Responsible Party

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Dong Jun Lim

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dong-Jun Lim, MD, PhD

Role: STUDY_CHAIR

Seoul St. Mary's Hospital

Locations

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Seoul St Mary's Hospital

Seoul, Seocho-Gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeonghoon Ha, MD

Role: CONTACT

Phone: +82-2-2258-6372

Email: [email protected]

Kwanhoon Jo, MD

Role: CONTACT

Phone: +82-2-2258-1220

Email: [email protected]

Facility Contacts

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Dong Jun Lim, MD,PhD

Role: primary

Kwanhoon Jo, MD

Role: backup

Other Identifiers

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KC16OISI0414

Identifier Type: -

Identifier Source: org_study_id