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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130402
First Posted: May 26, 2010
Last Update Posted: May 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Far Eastern Memorial Hospital
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 83 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 24, 2010
First Posted: May 26, 2010
Last Update Posted: May 26, 2010
Last Verified: April 2009

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

Additional relevant MeSH terms:
Lymphatic Diseases


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