A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy
This study has been completed.
Sponsor:
Far Eastern Memorial Hospital
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
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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 May 16, 2013