Active Surveillance of Papillary Thyroid Microcarcinoma

Active Surveillance of Papillary Thyroid Microcarcinoma (PTMC) in Catholic Medical Center

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"

Study Overview

• Status: Unknown
• Conditions: Thyroid Cancer, Papillary

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Jeonghoon Ha, MD; Phone Number: +82-2-2258-6372; Email: hajhoon@catholic.ac.kr
• Study Contact Backup: Name: Kwanhoon Jo, MD; Phone Number: +82-2-2258-1220; Email: lovi@naver.com

Study Locations

• Korea, Republic of
  • Seocho-Gu
    • Seoul, Seocho-Gu, Korea, Republic of, 137-701
      • Recruiting
      • Seoul St Mary's Hospital
      • Contact: Dong Jun Lim, MD,PhD; Phone Number: +82-2-2258-1220; Email: ldj6026@catholic.ac.kr
      • Contact: Kwanhoon Jo, MD; Phone Number: 82-2-2258-1220; Email: lovi@naver.com
      • Sub-Investigator: Jeonghoon Ha, MD
      • Sub-Investigator: Kwanhoon Jo, MD
      • Sub-Investigator: Jeongmin Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of papillary thyroid microcarcinoma	Using thyroid sonography, check any changes in size and shape of papillary thyroid microcarcinoma	5 years after enrollment

Collaborators and Investigators

• Sponsor: Dong Jun Lim
• Investigators: Study Chair: Dong-Jun Lim, MD, PhD, Seoul st. mary's hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 5, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Thyroid Neoplasms; Thyroid Diseases; Thyroid Cancer, Papillary
• Other Study ID Numbers: KC16OISI0414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes