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NCT01130402 Clinical Trial

A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy

Lymphadenopathy Clinical Trial

Official title:
A Real-time and Computerized Sonographic Scoring System for Predicting Malignant Cervical Lymphadenopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01130402
Other study ID # 098026-3
Secondary ID
Status Completed
Phase N/A
First received May 24, 2010
Last updated May 25, 2010
Start date June 2009
Est. completion date September 2009

Study information
Verified date April 2009
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

The investigaotors want to establish a real-time and computerized score reporting system based on the significant predictors of the measured sonographic parameters and demographic data.

Description:

One hundred eight patients with neck lymphadenopathy, receiving ultrasonography and ultrasound-guided fine-needle aspiration (US-FNA), were used to construct a predictive model. This model was validated by another independent patient cohort.

Recruitment information / eligibility
Status Completed
Enrollment 189
Est. completion date September 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 83 Years
Eligibility Inclusion Criteria:

- Patients with previously untreated neck masses underwent neck US

Exclusion Criteria:

- The neck mass was not lymph node

- No US-FNA cytology result

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Far Eastern Memorial Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Liao LJ, Wang CT, Young YH, Cheng PW. Real-time and computerized sonographic scoring system for predicting malignant cervical lymphadenopathy. Head Neck. 2010 May;32(5):594-8. doi: 10.1002/hed.21225. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The final diagnoses of lymph nodes were made by US-FNA cytological studies, pathologic results of the biopsy specimens, or at least 3 months of negative follow-up observations. 3 months No
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