Oral CancerNCT00174109
The Relation of Microtubule-Associated Protein 2 and Cell Migration
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Clarify the relation of microtubule-associated protein 2 and cell migration Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Oral Cancer
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2005to Jul 2006
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- oral cancer
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jenq-Yuh Ko, MD, PhD, 886-2-23123456 ext. 5222, kjycln@ha.mc.ntu.edu.tw
About this study
Clarify the relation of microtubule-associated protein 2 and cell migration
Read the detailed description
Betel quid chewing has been shown to have intimate correlation with oral cancer. In Taiwan, the incidence of oral cancer is the fourth most common malignancy in male and in fact, 90% of which has been linked to betel quid chewing. The predisposing factors in oral cancers between the western countries and India, Southeast Asia including Taiwan are different. The factor is smoking in the former countries and betel quid chewing is the most important one in the latter groups. The genetic aberrations of oral cancers are different too between the western countries and India, Southeast Asia including Taiwan. The percentage of RAS mutations of oral cancers in the western countries is around 5%, and 35% in the India. In Taiwan, the RAS mutation rate revealed with immunohistochemical staining is 92%, comparing with those in western countries (62%), Japan (55-65%) and vice versa in the p53 mutations. The percentage of p53 mutations of oral cancers in the western countries is around 50%, and 16% in the India, Southeast Asia and Taiwan. It is generally believed that betel nut itself, arecoline and arecaidine, the major betel alkaloids, account for the etiological factors in the pathogenesis of oral cancer while betel quid supplements, unlike the former two main components, were reported to have little relevancy to oral cancer. Despite the fact that the cytotoxic and genotoxic effects of betel nut extract and arecoline, arecaidine have been extensively documented, and that some well-studied oncogenes or tumor suppressor genes have been implicated in betel quid-related oral cancer, the molecular mechanisms, addressed in a broader view, by which betel nut ingredients lead to oral tumorigenesis are not fully understood. Our preliminary results, by virtue of different genome-wide screening approaches to explore cellular functions of protein kinases in this context, identified several candidates that showed differential expression upon treatment of BQ on primary cultures from human oral mucosa. Of the candidates isolated, microtubule-associated protein 2 (MAP2), a neuron-specific cytoskeletal protein that is thought to predominantly express in rat brain cells, was found up-regulated at RNA level by RT-PCR in primary cultures. Our expanded immunohistochemical results of normal mucosa, leukoplakia and oral squamous cell carcinoma (OSCC) suggest that expression of the MAP2 significantly correlates with progression of BQ-induced OSCC (P = 0.0046), since the percentage of MAP2 positive staining is as much fourfold in BQ-exposed OSCC (41.2%) as in BQ-free OSCC (10.5%), whereas normal mucosa and leukoplakia show much less immunoreactivity as a whole. Furthermore, the MAP2 is shown to be preferentially expressed in histopathologically less differentiated OSCC (P = 0.014). Finally, we show that the MAP2 is highly expressed in the majority of invasive OSCC (67%). Consequently, this finding, in conjunction with the previous one, raise a possibility that overexpression of the MAP2 may play a critical role in the development of highly malignant OSCC characteristic of invasive and/or metastatic. Here we study the issue by establishing an in vitro system where extracts from the whole betel quid sandwiches are used to treat head and neck cancer cell lines and primary oral epithelial cells and subsequently, the effects of such treatments will be evaluated in terms of cell migration, Western blotting. Eight head and neck cancer cell lines and normal oral mucosae from 8 patients undergoing oral surgery will be collected. Extracts from the whole betel quid sandwiches with the concentration of 1.5 mg/ml will be added to the cell lines and primary oral epithelial cells for 1,3 and 5 days, respectively. Migration assay and detection of MAP2 expression will be performed to elucidate the relationship of MAP2 and cell migration.
- Conditions
- Oral Cancer
- Keywords
- arecoline, oral cancer, MAP2, cell migration
- Medical subject headings
- Mouth Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies 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
- Natural history
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jenq-Yuh Ko, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174109
- Sponsor's protocol ID
- 9461700625
- Status last verified
- Jun 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation of Microtubule-Associated Protein 2 and Cell Migration
- ClinicalTrials.gov ID
- NCT00174109
- Acronym / sponsor ID
- 9461700625
- Conditions
- Oral Cancer
- Keywords
- arecoline, oral cancer, MAP2, cell migration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Jul 2006
- First posted
- 15 Sep 2005 (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.
Clarify the relation of microtubule-associated protein 2 and cell migration
Detailed description
Betel quid chewing has been shown to have intimate correlation with oral cancer. In Taiwan, the incidence of oral cancer is the fourth most common malignancy in male and in fact, 90% of which has been linked to betel quid chewing. The predisposing factors in oral cancers between the western countries and India, Southeast Asia including Taiwan are different. The factor is smoking in the former countries and betel quid chewing is the most important one in the latter groups. The genetic aberrations of oral cancers are different too between the western countries and India, Southeast Asia including Taiwan. The percentage of RAS mutations of oral cancers in the western countries is around 5%, and 35% in the India. In Taiwan, the RAS mutation rate revealed with immunohistochemical staining is 92%, comparing with those in western countries (62%), Japan (55-65%) and vice versa in the p53 mutations. The percentage of p53 mutations of oral cancers in the western countries is around 50%, and 16% in the India, Southeast Asia and Taiwan. It is generally believed that betel nut itself, arecoline and arecaidine, the major betel alkaloids, account for the etiological factors in the pathogenesis of oral cancer while betel quid supplements, unlike the former two main components, were reported to have little relevancy to oral cancer. Despite the fact that the cytotoxic and genotoxic effects of betel nut extract and arecoline, arecaidine have been extensively documented, and that some well-studied oncogenes or tumor suppressor genes have been implicated in betel quid-related oral cancer, the molecular mechanisms, addressed in a broader view, by which betel nut ingredients lead to oral tumorigenesis are not fully understood. Our preliminary results, by virtue of different genome-wide screening approaches to explore cellular functions of protein kinases in this context, identified several candidates that showed differential expression upon treatment of BQ on primary cultures from human oral mucosa. Of the candidates isolated, microtubule-associated protein 2 (MAP2), a neuron-specific cytoskeletal protein that is thought to predominantly express in rat brain cells, was found up-regulated at RNA level by RT-PCR in primary cultures. Our expanded immunohistochemical results of normal mucosa, leukoplakia and oral squamous cell carcinoma (OSCC) suggest that expression of the MAP2 significantly correlates with progression of BQ-induced OSCC (P = 0.0046), since the percentage of MAP2 positive staining is as much fourfold in BQ-exposed OSCC (41.2%) as in BQ-free OSCC (10.5%), whereas normal mucosa and leukoplakia show much less immunoreactivity as a whole. Furthermore, the MAP2 is shown to be preferentially expressed in histopathologically less differentiated OSCC (P = 0.014). Finally, we show that the MAP2 is highly expressed in the majority of invasive OSCC (67%). Consequently, this finding, in conjunction with the previous one, raise a possibility that overexpression of the MAP2 may play a critical role in the development of highly malignant OSCC characteristic of invasive and/or metastatic. Here we study the issue by establishing an in vitro system where extracts from the whole betel quid sandwiches are used to treat head and neck cancer cell lines and primary oral epithelial cells and subsequently, the effects of such treatments will be evaluated in terms of cell migration, Western blotting. Eight head and neck cancer cell lines and normal oral mucosae from 8 patients undergoing oral surgery will be collected. Extracts from the whole betel quid sandwiches with the concentration of 1.5 mg/ml will be added to the cell lines and primary oral epithelial cells for 1,3 and 5 days, respectively. Migration assay and detection of MAP2 expression will be performed to elucidate the relationship of MAP2 and cell migration.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- oral cancer
Key exclusion criteria (1 listed)
- nil
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 15 Sep 2005.
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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.
Jenq-Yuh Ko, MD, PhD 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 Oral Cancer, 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 Sep 2005. 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 Jenq-Yuh Ko, MD, PhD (886-2-23123456 ext. 5222, kjycln@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 Sep 2005.