Neck MassNCT01301690
Development of a Novel Methodology Using BMVC Staining as an Assistance to Cancer Cytological Diagnosis
An observational study of Neck Mass, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
3,6-bis(1-methyl-4-vinylpyridinium) carbazole diiodide (BMVC) is an inorganic chemical compound (Figure1). The uptake of BMVC in cancer cells and normal cells are different. Recently, a simple handheld device (Figure1) based on the fluorescence analysis of stained cells was established to instantly differentiate… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neck Mass
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to not given
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We propose to collect consecutive patients (age range from 18 to 90 years old) with neck lumps, receiving sonographic examination and FNA cytologic study.
Who may be able to join
- patients (age range from 18 to 90 years old) with neck lumps, receiving sonographic examination and FNA cytologic study.
Who cannot join
- No cytology data
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Otolaryngology Far Eastern Memorial Hospital
Taipei
Shih-Hong Huang, M.D., Ph.D., +886 0 89671592, irb@mail.femh.org.tw
About this study
3,6-bis(1-methyl-4-vinylpyridinium) carbazole diiodide (BMVC) is an inorganic chemical compound (Figure1). The uptake of BMVC in cancer cells and normal cells are different. Recently, a simple handheld device (Figure1) based on the fluorescence analysis of stained cells was established to instantly differentiate cancer cells from normal cells. The investigators want to quantitatively measure the fluorescence expression of BMVC in normal and cancer cells and explore the usefulness of this staining in head and neck lumps.
- Conditions
- Neck Mass
- Keywords
- neck mass, ultrasound, FNA, BMVC
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 | Neck mass received US and US-FNA |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJan 2010
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 Neck MassStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Jen Liao, Far Eastern Memorial Hospital
- Investigators
- Li-Jen Liao, MD, Study director, Department of Otolaryngology Far Eastern Memorial Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301690
- Sponsor's protocol ID
- FEMH No.:98041-3
- Status last verified
- Sep 2011
- First submitted
- 21 Feb 2011
- Last updated
- 19 Sep 2011
- Results posted
- No
Publications
Liao LJ, Kang CC, Jan IS, Chen HC, Wang CL, Lou PJ, Chang TC. Improved diagnostic accuracy of malignant neck lumps by a simple BMVC staining assay. Analyst. 2009 Apr;134(4):708-11. doi: 10.1039/b814417f. Epub 2009 Jan 24.
PubMed 19305919
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Methodology Using BMVC Staining as an Assistance to Cancer Cytological Diagnosis
- ClinicalTrials.gov ID
- NCT01301690
- Acronym / sponsor ID
- FEMH No.:98041-3
- Conditions
- Neck Mass
- Keywords
- neck mass, ultrasound, FNA, BMVC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2010
- First posted
- 23 Feb 2011 (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.
3,6-bis(1-methyl-4-vinylpyridinium) carbazole diiodide (BMVC) is an inorganic chemical compound (Figure1). The uptake of BMVC in cancer cells and normal cells are different. Recently, a simple handheld device (Figure1) based on the fluorescence analysis of stained cells was established to instantly differentiate cancer cells from normal cells. The investigators want to quantitatively measure the fluorescence expression of BMVC in normal and cancer cells and explore the usefulness of this staining in head and neck lumps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neck masses | – | –Neck mass received US and US-FNA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We propose to collect consecutive patients (age range from 18 to 90 years old) with neck lumps, receiving sonographic examination and FNA cytologic study.
Key inclusion criteria (1 listed)
- patients (age range from 18 to 90 years old) with neck lumps, receiving sonographic examination and FNA cytologic study.
Key exclusion criteria (1 listed)
- No cytology data
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2011.
- Background: PubMed 19305919Liao LJ, Kang CC, Jan IS, Chen HC, Wang CL, Lou PJ, Chang TC. Improved diagnostic accuracy of malignant neck lumps by a simple BMVC staining assay. Analyst. 2009 Apr;134(4):708-11. doi: 10.1039/b814417f. Epub 2009 Jan 24.
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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 Neck Mass, 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 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Jen Liao, MD (+886-0-8967-1592, deniro@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01301690, 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 19 Sep 2011.