Active Surveillance of Papillary Thyroid Microcarcinoma

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02952612

Enrollment

300

Registered

2016-11-02

Start date

2016-10-31

Completion date

2021-10-31

Last updated

2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer, Papillary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Contacts

Primary ContactJeonghoon Ha, MD

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

Backup ContactKwanhoon Jo, MD

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

Outcome results