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Trial Title:
Active Surveillance for Low-risk Papillary Thyroid Carcinoma
NCT ID:
NCT06261190
Condition:
Thyroid Cancer
Papillary Thyroid Carcinoma
Conditions: Official terms:
Carcinoma
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Conditions: Keywords:
Active Surveillance
Immediate surgery
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
This study is an observational cohort study targeting patients with low-risk Papillary
thyroid cancer who opted for active surveillance or immediate surgery based on a
sufficient understanding of the treatment options. The primary objective of the study is
to evaluate progression free survival of the patients with low-risk Papillary thyroid
cancer who choose active surveillance, in other words, to observe the natural course of
low-risk Papillary thyroid cancer.
Criteria for eligibility:
Study pop:
Subjects aged older than 18 years with the tumor size of ≤ 1.5 cm papillary thyroid
carcinoma, who meet the inclusion criteria from Seoul National University Hospital,
National Cancer Center, Seoul National University Bundang Hospital, and SMG-SNU Boramae
Medical Center.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- subjects over 18 years old with a thyroid nodule of ≤ 1.5 cm in maximum diameter and
a Bethesda category V or VI diagnosis on cytopathology
- subjects without high-risk features, including lymph node (LN) metastasis, distant
metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or
trachea, Poorly differentiated cancer or variant with a poor prognosis, such as the
tall cell, diffuse sclerosing, columnar cell, or solid variants.
Exclusion Criteria:
- subjects who are unable or unwilling to attend regular follow-ups..
- subjects with a diagnosis of benign, atypia of undetermined significance, suspicious
for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV)
based on Fine needle aspiration or, or benign, indeterminate by core needle biopsy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Country:
Korea, Republic of
Investigator:
Last name:
Eun Kyung Lee
Email:
Principal Investigator
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Country:
Korea, Republic of
Investigator:
Last name:
Jae Hoon Moon
Email:
Principal Investigator
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Investigator:
Last name:
Young Joo Park
Email:
Principal Investigator
Facility:
Name:
SMC-SNU Boramae Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Investigator:
Last name:
Ka Hi Lee
Email:
Principal Investigator
Start date:
March 4, 2024
Completion date:
December 31, 2032
Lead sponsor:
Agency:
National Cancer Center, Korea
Agency class:
Other
Collaborator:
Agency:
Seoul National University Bundang Hospital
Agency class:
Other
Collaborator:
Agency:
SMG-SNU Boramae Medical Center
Agency class:
Other
Collaborator:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
National Cancer Center, Korea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06261190
