Active Surveillance of Papillary Thyroid Microcarcinoma

Thyroid Cancer, Papillary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02952612
• Other study ID #: KC16OISI0414
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2016
• Last updated: November 5, 2016
• Start date: October 2016
• Est. completion date: October 2021

Study information

• Verified date: November 2016
• Source: Seoul St. Mary's Hospital
• Contact: Jeonghoon Ha, MD
• Phone: +82-2-2258-6372
• Email: hajhoon[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial 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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2021
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul St Mary's Hospital	Seoul	Seocho-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Dong Jun Lim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of papillary thyroid microcarcinoma	Using thyroid sonography, check any changes in size and shape of papillary thyroid microcarcinoma	5 years after enrollment	No