NCT01137097

Brief Summary

Objective: To investigate the incidence of lateral neck node occult metastasis and to show the usefulness of sentinel lymph node biopsy (SLNB) in the detection of lateral neck node metastasis in thyroid carcinoma, the investigators used a radioisotope to detect the sentinel lymph node. Summary Background Data: Although occult lymph node metastasis to the lateral neck compartment is common in papillary thyroid carcinoma, the incidence and patterns of lateral neck node metastasis in papillary carcinoma are not known.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

June 2, 2010

Last Update Submit

April 20, 2016

Conditions

Thyroid Neoplasm

Outcome Measures

Primary Outcomes (1)

  • The usefulness of lateral sentinel lymph node biopsy in PTC

    at Oct 2011

Study Arms (2)

Lateral sentinel group

ACTIVE COMPARATOR

Lateral sentinel lymph node biopsy with radioisotope

Procedure: Lateral sentinel lymph node biopsy

No intervention for lateral neck

NO INTERVENTION

No lateral sentinel lymph node biopsy with radioisotope

Interventions

Lateral sentinel lymph node biopsyPROCEDURE

Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively

Lateral sentinel group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases with tumors larger than 1 cm in size or with suspicious central neck node metastasis in Papillary thyroid cancer

You may not qualify if:

  • The patient with definite metastatic lymph node in lateral neck compartment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Se Kyung Lee, M.D

    Samsung Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Association professor

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 4, 2010

Study Start

June 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 21, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)