LymphadenopathyNCT01130402
A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy
An observational study of Lymphadenopathy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 10 to 83 years
- Conditions the study is for
- Lymphadenopathy
- How many people
- 189 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 83 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with previously untreated neck masses underwent neck US
Who cannot join
- The neck mass was not lymph node
- No US-FNA cytology result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-time and Computerized Sonographic Scoring System for Predicting Malignant Cervical Lymphadenopathy
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.
Read the 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.
- Conditions
- Lymphadenopathy
- Keywords
- age, lymphadenopathy, fine needle aspiration, sonography
- Medical subject headings
- Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neck masses | Patients with previously untreated neck masses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphadenopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Li-Jen Liao, MD, Study director, Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130402
- Sponsor's protocol ID
- 098026-3
- Status last verified
- Apr 2009
- First submitted
- 24 May 2010
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19693943
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-time and Computerized Sonographic Scoring System for Predicting Malignant Cervical Lymphadenopathy
- ClinicalTrials.gov ID
- NCT01130402
- Acronym / sponsor ID
- 098026-3
- Conditions
- Lymphadenopathy
- Keywords
- age, lymphadenopathy, fine needle aspiration, sonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Study completion
- Sep 2009 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neck masses | – | –Patients with previously untreated neck masses |
Who may qualify
- Ages
- 10 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with previously untreated neck masses underwent neck US
Key exclusion criteria (2 listed)
- The neck mass was not lymph node
- No US-FNA cytology result
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
- Results publication: PubMed 19693943Liao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Jen Liao, MD study director
Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphadenopathy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01130402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2010.