Active Surveillance of Papillary Thyroid Microcarcinoma

NCT02952612 | Unknown

• 1 other identifier: KC16OISI0414
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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"

Conditions

Thyroid Cancer, Papillary

Outcome Measures

Primary Outcomes (1)

• Progression of papillary thyroid microcarcinoma

  Using thyroid sonography, check any changes in size and shape of papillary thyroid microcarcinoma

  5 years after enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \< 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

You may not qualify if:

• ≥ 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

Sponsors & Collaborators

• Dong Jun Lim: lead

Study Sites (1)

Seoul St Mary's Hospital

Seoul, Seocho-Gu, 137-701, South Korea

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Dong-Jun Lim, MD, PhD

  Seoul St. Mary's Hospital

  STUDY CHAIR

Central Study Contacts

Jeonghoon Ha, MD

CONTACT

+82-2-2258-6372; hajhoon@catholic.ac.kr

Kwanhoon Jo, MD

CONTACT

+82-2-2258-1220; lovi@naver.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2021
• Last Updated: November 8, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)