Glycosyltion Enzymes and Function AbnormalitiesNCT01976377
Mucin Glycosylating Enzymes in Head and Neck Cancers
An observational study of Glycosyltion Enzymes and Function Abnormalities, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is the hallmark of most human cancers, including HNSCC, and affects many cellular properties. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Glycosyltion Enzymes and Function Abnormalities
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Oct 2017
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Head and neck cancer patients receiving operation in National Taiwan University Hospital
Who may be able to join
- Head and neck cancer patients receiving operation in National Taiwan University Hospital
Who cannot join
- Recurrence or non-operable patients
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei, Taiwan, 100
Pei-Jen Lou, MD, PhD, 886-972651527, pjlou@ntu.edu.tw
Mei-Chun Lin, 886-978261268, b91401051@ntu.edu.tw
About this study
Official title: Expression of Mucin Glycosylating Enzymes in Head and Neck Cancers and Its Correlation With Clinico-pathological Parameters.
Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is the hallmark of most human cancers, including HNSCC, and affects many cellular properties. This study is aimed at exploring the role of mucin glycosylating enzymes in HNSCC.
Read the detailed description
Glycosylation is the most common post-translational modification of proteins. Aberrant glycosylation is the hallmark of most human cancers and affect many cellular properties, including cell proliferation, apoptosis, differentiation, transformation, migration and immune response.
Though widely explored in various human cancers, the role of mucin glycosylating enzymes in HNSCC has not been elucidated. Our aims is to analyze the expression patterns of mucin glycosylating enzymes in HNSCC tissues. Furthermore, we will correlate the expression levels of mucin glycosylating enzymes with clinical characteristics of HNSCC patients.
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 |
|---|---|---|
| Stage I, II, III, IV HNSCC | Stage I, II, III, IV HNSCC reveive treatment in NTUH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the expression of mucin glycosylating in head and neck cancer
Measured: 1~5 years after patient received surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycosyltion Enzymes and Function AbnormalitiesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Jen Lou, M.D, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976377
- Sponsor's protocol ID
- 201307074RIND
- Status last verified
- Dec 2016
- First submitted
- 22 Oct 2013
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Mucin Glycosylating Enzymes in Head and Neck Cancers and Its Correlation With Clinico-pathological Parameters.
- ClinicalTrials.gov ID
- NCT01976377
- Acronym / sponsor ID
- 201307074RIND
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 5 Nov 2013 (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.
Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is the hallmark of most human cancers, including HNSCC, and affects many cellular properties. This study is aimed at exploring the role of mucin glycosylating enzymes in HNSCC.
Detailed description
Glycosylation is the most common post-translational modification of proteins. Aberrant glycosylation is the hallmark of most human cancers and affect many cellular properties, including cell proliferation, apoptosis, differentiation, transformation, migration and immune response.
Though widely explored in various human cancers, the role of mucin glycosylating enzymes in HNSCC has not been elucidated. Our aims is to analyze the expression patterns of mucin glycosylating enzymes in HNSCC tissues. Furthermore, we will correlate the expression levels of mucin glycosylating enzymes with clinical characteristics of HNSCC patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage I, II, III, IV HNSCC | – | –Stage I, II, III, IV HNSCC reveive treatment in NTUH |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck cancer patients receiving operation in National Taiwan University Hospital
Key inclusion criteria (1 listed)
- Head and neck cancer patients receiving operation in National Taiwan University Hospital
Key exclusion criteria (1 listed)
- Recurrence or non-operable patients
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
Measure the expression of mucin glycosylating in head and neck cancer
Time frame: 1~5 years after patient received surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
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.
Pei-Jen Lou, M.D, Ph.D principal investigator
National Taiwan University Hospital
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 Glycosyltion Enzymes and Function Abnormalities, run by National Taiwan University 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 15 Dec 2016. 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 Pei-Jen Lou, M.D, Ph.D (886-972651527, pjlou@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the expression of mucin glycosylating in head and neck cancer (time frame: 1~5 years after patient received surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2016.