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

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ClinicalTrials.gov Identifier: NCT01130402
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 26, 2010
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease
Lymphadenopathy

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.

Study Design

Study Type : Observational
Actual Enrollment : 189 participants
Time Perspective: Retrospective
Official Title: A Real-time and Computerized Sonographic Scoring System for Predicting Malignant Cervical Lymphadenopathy
Study Start Date : June 2009
Study Completion Date : September 2009
Groups and Cohorts

Group/Cohort
Neck masses
Patients with previously untreated neck masses


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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 Posted: May 26, 2010    Key Record Dates
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:
Lymphadenopathy
Lymphatic Diseases