Oral CancerNCT02648789
Validation of DNA Methylation Biomarkers for Oral Cancer Detection
An observational study of Oral Cancer and Recurrence, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the correlation between DNA methylation and the treatment and recurrence of oral cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Oral Cancer, Recurrence
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2015to May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators plan to retrieve the tissue from the biobank in Taipei Veterans General Hospital or recruit oral cancer patients in this study over six months. The total patient number are 40-50. Specimen types include non-cancerous matched tissues, cancer tissues, and the oral swab. DNA methylation for several genes will be tested by using standardized reagents and instruments.
Who may be able to join
- Age between 20 and 75 years old
- Had or currently has cancer of the oral cavity
- Agree to sign the Informed Consent Form (ICF) and comply with follow-up procedures
Who cannot join
- Unwilling to sign the Informed Consent Form (ICF)
- Has an autoimmune disease of the oral cavity
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the correlation between DNA methylation and the treatment and recurrence of oral cancer.
Read the detailed description
In this study, investigators plan to recruit 40~50 patients who had, or currently has oral cancer. The study procedures are as below:
- After the Informed Consent Form is signed, swab from the lesion site and normal site to obtain oral epithelial cells.
- Collect tissue from the tumor site and the non-cancerous matched site from the surgery or the tissue bank.
- Collect oral swab from the lesion site and the normal site when patients return to the clinic for a regular follow-up.
Specimens will be collected for DNA methylation testing, and the results will be compared with patient's clinical diagnosis. It is expected that the relationship between DNA methylation, oral cancer, and the recurrence of oral cancer will be found.
- Conditions
- Oral Cancer, Recurrence
- Keywords
- Primary oral cancer, DNA methylation, Recurrence oral cancer
- Medical subject headings
- Mouth Neoplasms, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the DNA methylation level and the stage of cancer
- Compare the DNA methylation level and the stage of cancer before treatment.
- DNA methylation level as a monitor tool for recurrence/metastasis of oral cancer.
- qPCR will be used to determine the DNA methylation level.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- iStat Biomedical CO., Ltd.
- Responsible party
- Sponsor
- Investigators
- Cheng-Chieh Yang, DDS., Ph.D., Principal investigator, Department of Stomatology, Taipei Veterans General HospitalShou-Yen Kao, DDS., M.D.S., Principal investigator, Department of Stomatology, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648789
- Sponsor's protocol ID
- 2015-06-009AC
- Status last verified
- May 2017
- First submitted
- 19 Nov 2015
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang SS, Smiraglia DJ, Wu YZ, Ghosh S, Rader JS, Cho KR, Bonfiglio TA, Nayar R, Plass C, Sherman ME. Identification of novel methylation markers in cervical cancer using restriction landmark genomic scanning. Cancer Res. 2008 Apr 1;68(7):2489-97. doi: 10.1158/0008-5472.CAN-07-3194.
PubMed 18381458Sova P, Feng Q, Geiss G, Wood T, Strauss R, Rudolf V, Lieber A, Kiviat N. Discovery of novel methylation biomarkers in cervical carcinoma by global demethylation and microarray analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):114-23. doi: 10.1158/1055-9965.EPI-05-0323.
PubMed 16434596Lai HC, Lin YW, Chang CC, Wang HC, Chu TW, Yu MH, Chu TY. Hypermethylation of two consecutive tumor suppressor genes, BLU and RASSF1A, located at 3p21.3 in cervical neoplasias. Gynecol Oncol. 2007 Mar;104(3):629-35. doi: 10.1016/j.ygyno.2006.10.003. Epub 2006 Nov 13.
PubMed 17097722Towle R, Garnis C. Methylation-mediated molecular dysregulation in clinical oral malignancy. J Oncol. 2012;2012:170172. doi: 10.1155/2012/170172. Epub 2012 May 7.
PubMed 22645611Garcia MP, Garcia-Garcia A. Epigenome and DNA methylation in oral squamous cell carcinoma. Methods Mol Biol. 2012;863:207-19. doi: 10.1007/978-1-61779-612-8_12.
PubMed 22359295Nagata S, Hamada T, Yamada N, Yokoyama S, Kitamoto S, Kanmura Y, Nomura M, Kamikawa Y, Yonezawa S, Sugihara K. Aberrant DNA methylation of tumor-related genes in oral rinse: a noninvasive method for detection of oral squamous cell carcinoma. Cancer. 2012 Sep 1;118(17):4298-308. doi: 10.1002/cncr.27417. Epub 2012 Jan 17.
PubMed 22252571Fakhry C, Gillison ML. Clinical implications of human papillomavirus in head and neck cancers. J Clin Oncol. 2006 Jun 10;24(17):2606-11. doi: 10.1200/JCO.2006.06.1291.
PubMed 16763272Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.
PubMed 18235120Huang YK, Peng BY, Wu CY, Su CT, Wang HC, Lai HC. DNA methylation of PAX1 as a biomarker for oral squamous cell carcinoma. Clin Oral Investig. 2014 Apr;18(3):801-8. doi: 10.1007/s00784-013-1048-6. Epub 2013 Aug 2.
PubMed 23907469
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of DNA Methylation Biomarkers for Oral Cancer Detection
- ClinicalTrials.gov ID
- NCT02648789
- Acronym / sponsor ID
- 2015-06-009AC
- Conditions
- Oral Cancer, Recurrence
- Keywords
- Primary oral cancer, DNA methylation, Recurrence oral cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- iStat Biomedical CO., Ltd.
- Study start
- May 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 Jan 2016 (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 purpose of this study is to investigate the correlation between DNA methylation and the treatment and recurrence of oral cancer.
Detailed description
In this study, investigators plan to recruit 40~50 patients who had, or currently has oral cancer. The study procedures are as below:
- After the Informed Consent Form is signed, swab from the lesion site and normal site to obtain oral epithelial cells.
- Collect tissue from the tumor site and the non-cancerous matched site from the surgery or the tissue bank.
- Collect oral swab from the lesion site and the normal site when patients return to the clinic for a regular follow-up.
Specimens will be collected for DNA methylation testing, and the results will be compared with patient's clinical diagnosis. It is expected that the relationship between DNA methylation, oral cancer, and the recurrence of oral cancer will be found.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators plan to retrieve the tissue from the biobank in Taipei Veterans General Hospital or recruit oral cancer patients in this study over six months. The total patient number are 40-50. Specimen types include non-cancerous matched tissues, cancer tissues, and the oral swab. DNA methylation for several genes will be tested by using standardized reagents and instruments.
Key inclusion criteria (3 listed)
- Age between 20 and 75 years old
- Had or currently has cancer of the oral cavity
- Agree to sign the Informed Consent Form (ICF) and comply with follow-up procedures
Key exclusion criteria (2 listed)
- Unwilling to sign the Informed Consent Form (ICF)
- Has an autoimmune disease of the oral cavity
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
Association between the DNA methylation level and the stage of cancer
Time frame: 1 year
1. Compare the DNA methylation level and the stage of cancer before treatment. 2. DNA methylation level as a monitor tool for recurrence/metastasis of oral cancer. 3. qPCR will be used to determine the DNA methylation level.
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 9 Aug 2018.
- Background: PubMed 18381458Wang SS, Smiraglia DJ, Wu YZ, Ghosh S, Rader JS, Cho KR, Bonfiglio TA, Nayar R, Plass C, Sherman ME. Identification of novel methylation markers in cervical cancer using restriction landmark genomic scanning. Cancer Res. 2008 Apr 1;68(7):2489-97. doi: 10.1158/0008-5472.CAN-07-3194.
- Background: PubMed 16434596Sova P, Feng Q, Geiss G, Wood T, Strauss R, Rudolf V, Lieber A, Kiviat N. Discovery of novel methylation biomarkers in cervical carcinoma by global demethylation and microarray analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):114-23. doi: 10.1158/1055-9965.EPI-05-0323.
- Background: PubMed 17097722Lai HC, Lin YW, Chang CC, Wang HC, Chu TW, Yu MH, Chu TY. Hypermethylation of two consecutive tumor suppressor genes, BLU and RASSF1A, located at 3p21.3 in cervical neoplasias. Gynecol Oncol. 2007 Mar;104(3):629-35. doi: 10.1016/j.ygyno.2006.10.003. Epub 2006 Nov 13.
- Background: PubMed 22645611Towle R, Garnis C. Methylation-mediated molecular dysregulation in clinical oral malignancy. J Oncol. 2012;2012:170172. doi: 10.1155/2012/170172. Epub 2012 May 7.
- Background: PubMed 22359295Garcia MP, Garcia-Garcia A. Epigenome and DNA methylation in oral squamous cell carcinoma. Methods Mol Biol. 2012;863:207-19. doi: 10.1007/978-1-61779-612-8_12.
- Background: PubMed 22252571Nagata S, Hamada T, Yamada N, Yokoyama S, Kitamoto S, Kanmura Y, Nomura M, Kamikawa Y, Yonezawa S, Sugihara K. Aberrant DNA methylation of tumor-related genes in oral rinse: a noninvasive method for detection of oral squamous cell carcinoma. Cancer. 2012 Sep 1;118(17):4298-308. doi: 10.1002/cncr.27417. Epub 2012 Jan 17.
- Background: PubMed 16763272Fakhry C, Gillison ML. Clinical implications of human papillomavirus in head and neck cancers. J Clin Oncol. 2006 Jun 10;24(17):2606-11. doi: 10.1200/JCO.2006.06.1291.
- Background: PubMed 18235120Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.
- Background: PubMed 23907469Huang YK, Peng BY, Wu CY, Su CT, Wang HC, Lai HC. DNA methylation of PAX1 as a biomarker for oral squamous cell carcinoma. Clin Oral Investig. 2014 Apr;18(3):801-8. doi: 10.1007/s00784-013-1048-6. Epub 2013 Aug 2.
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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.
Cheng-Chieh Yang, DDS., Ph.D. principal investigator
Department of Stomatology, Taipei Veterans General Hospital
Shou-Yen Kao, DDS., M.D.S. principal investigator
Department of Stomatology, Taipei Veterans General 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 and Recurrence, run by Taipei Veterans General Hospital, Taiwan 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 3 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 9 Aug 2018. 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?
Association between the DNA methylation level and the stage of cancer (time frame: 1 year). 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 NCT02648789, which also lists 9 linked publications.
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 9 Aug 2018.