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

This study has been completed.
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01130402
First received: May 24, 2010
Last updated: May 25, 2010
Last verified: April 2009
  Purpose

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.


Condition
Lymphadenopathy

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Real-time and Computerized Sonographic Scoring System for Predicting Malignant Cervical Lymphadenopathy

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: June 2009
Study Completion Date: September 2009
Groups/Cohorts
Neck masses
Patients with previously untreated neck masses

Detailed 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.

  Eligibility

Ages Eligible for Study:   10 Years to 83 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with previously untreated neck masses were referred for sonographic evaluation and subsequent US-FNA after informed consent was obtained. Demographic data, including age and sex, side, site, and number of lymphadenopathy was collected as well.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130402

Locations
Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Study Director: Li-Jen Liao, MD Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan
  More Information

Additional Information:
Publications:
Responsible Party: Research Ethics Review Committee, Far Eastern Memorial Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier: NCT01130402     History of Changes
Other Study ID Numbers: 098026-3
Study First Received: May 24, 2010
Last Updated: May 25, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
age
lymphadenopathy
fine needle aspiration
sonography

Additional relevant MeSH terms:
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014