CarcinogenesisNCT01919567
Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.
An observational study of Carcinogenesis and Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinogenesis, Oral Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 255 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2011to Apr 2014
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical center
Who may be able to join
- Dysplasia or cancer of the oral cavity.
Who cannot join
- pregnant woman
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital research Ethics Committee
Taipei, 10048
Shin-Jung Cheng, DDS, MS, PhD, +886 2 29251733 ext. 67509, sjcheng56@ntu.edu.tw
Shin-Jung Cheng, DDS, MS, PhD
About this study
Official title: Observational Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.
Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.
Read the detailed description
To find out if there is prognostic value which to the performance of SOX-9 of oral cancer in Taiwan and provide some reference for future treatment.
We anticipate to enroll 40 persons with normal oral mucosa, 65 persons with oral dysplasia and 150 persons with oral cancer and collect the tissue which was stained for pathological sections over a 3 year period.
We also collect the blood and saliva samples from patients and the results along with patient-specific information such as tumor phases, tumor size, lymph node metastasis, cancer metastasis, prognosis and betel nut chewing, smoking and drinking habits and other parameters are statistically analyzed.
- Conditions
- Carcinogenesis, Oral Cancer
- Keywords
- SOX-9, Oral cancer, arecoline
- Medical subject headings
- Carcinogenesis, Mouth Neoplasms
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 |
|---|---|---|
| Normal team | Subjects who have problem at third molar of impacted tooth need to receive a surgery with general anesthesia. Subjects must: Should have a blood exam (20ml) before the surgery. Site staff must: Collect subjects' saliva once a day (in the morning before breakfast) for 3 consecutive days. Collect a 0.5x0.5Cm2 tissue sample around third molar during the surgery. | |
| Oral dysplasia | Subjects who are diagnosed with dysplasia of oral cavity. Subjects must: Should have a blood exam (20ml/each time) before the surgery and 3 months after the surgery. In the case the disease recurs after the surgery, subjects need to receive the surgery again and take another blood exam before the surgery and 3 months after the surgery. Before the surgery site staff must: Collect saliva once a day (in the morning before breakfast) for 3 consecutive days. Collect a 0.5x0.5Cm2 tissue sample of the tumor during the surgery. | |
| Oral cancer | Subjects who suffer from oral cancer. Subjects must: Should have a blood exam (20ml/each time) before the surgery and 3 months after the surgery. In the case the disease recurs after the surgery, subjects need to receive the surgery again and take another blood exam before the surgery and 3 months after the surgery. Before the surgery site staff must: Collect subjects' saliva once a day (in the morning before breakfast) for 3 consecutive days. Collect a 0.5x0.5Cm2 tissue sample of the tumor during the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carcinogenesis of SOX-9
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startNov 2011
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for CarcinogenesisStudies 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
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shin-Jung Cheng, DDS, MS, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919567
- Sponsor's protocol ID
- 201012095RC
- Status last verified
- Nov 2013
- First submitted
- 7 Aug 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Afonja O, Raaka BM, Huang A, Das S, Zhao X, Helmer E, Juste D, Samuels HH. RAR agonists stimulate SOX9 gene expression in breast cancer cell lines: evidence for a role in retinoid-mediated growth inhibition. Oncogene. 2002 Nov 7;21(51):7850-60. doi: 10.1038/sj.onc.1205985.
PubMed 12420222Aleman A, Adrien L, Lopez-Serra L, Cordon-Cardo C, Esteller M, Belbin TJ, Sanchez-Carbayo M. Identification of DNA hypermethylation of SOX9 in association with bladder cancer progression using CpG microarrays. Br J Cancer. 2008 Jan 29;98(2):466-73. doi: 10.1038/sj.bjc.6604143. Epub 2007 Dec 18.
PubMed 18087279Alvarez-Medina R, Le Dreau G, Ros M, Marti E. Hedgehog activation is required upstream of Wnt signalling to control neural progenitor proliferation. Development. 2009 Oct;136(19):3301-9. doi: 10.1242/dev.041772.
PubMed 19736325Bien-Willner GA, Stankiewicz P, Lupski JR. SOX9cre1, a cis-acting regulatory element located 1.1 Mb upstream of SOX9, mediates its enhancement through the SHH pathway. Hum Mol Genet. 2007 May 15;16(10):1143-56. doi: 10.1093/hmg/ddm061. Epub 2007 Apr 4.
PubMed 17409199Lu B, Fang Y, Xu J, Wang L, Xu F, Xu E, Huang Q, Lai M. Analysis of SOX9 expression in colorectal cancer. Am J Clin Pathol. 2008 Dec;130(6):897-904. doi: 10.1309/AJCPW1W8GJBQGCNI.
PubMed 19019766Drivdahl R, Haugk KH, Sprenger CC, Nelson PS, Tennant MK, Plymate SR. Suppression of growth and tumorigenicity in the prostate tumor cell line M12 by overexpression of the transcription factor SOX9. Oncogene. 2004 Jun 3;23(26):4584-93. doi: 10.1038/sj.onc.1207603.
PubMed 15077158Wang H, Leav I, Ibaragi S, Wegner M, Hu GF, Lu ML, Balk SP, Yuan X. SOX9 is expressed in human fetal prostate epithelium and enhances prostate cancer invasion. Cancer Res. 2008 Mar 15;68(6):1625-30. doi: 10.1158/0008-5472.CAN-07-5915.
PubMed 18339840Jay P, Berta P, Blache P. Expression of the carcinoembryonic antigen gene is inhibited by SOX9 in human colon carcinoma cells. Cancer Res. 2005 Mar 15;65(6):2193-8. doi: 10.1158/0008-5472.CAN-04-1484.
PubMed 15781631Knower KC, Kelly S, Harley VR. Turning on the male--SRY, SOX9 and sex determination in mammals. Cytogenet Genome Res. 2003;101(3-4):185-98. doi: 10.1159/000074336.
PubMed 14684982Ishida K, Ito S, Wada N, Deguchi H, Hata T, Hosoda M, Nohno T. Nuclear localization of beta-catenin involved in precancerous change in oral leukoplakia. Mol Cancer. 2007 Oct 9;6:62. doi: 10.1186/1476-4598-6-62.
PubMed 17922924Mertin S, McDowall SG, Harley VR. The DNA-binding specificity of SOX9 and other SOX proteins. Nucleic Acids Res. 1999 Mar 1;27(5):1359-64. doi: 10.1093/nar/27.5.1359.
PubMed 9973626Murata M, Iwao K, Miyoshi Y, Nagasawa Y, Yabu M, Himeno S, Imanishi K, Ohsawa M, Wada H, Tominaga S, Shimano T, Kobayashi T, Nakamura Y. Activation of the beta-catenin gene by interstitial deletions involving exon 3 as an early event in colorectal tumorigenesis. Cancer Lett. 2000 Oct 16;159(1):73-8. doi: 10.1016/s0304-3835(00)00533-4.
PubMed 10974408Fracalossi AC, Silva Mde S, Oshima CT, Ribeiro DA. Wnt/beta-catenin signalling pathway following rat tongue carcinogenesis induced by 4-nitroquinoline 1-oxide. Exp Mol Pathol. 2010 Feb;88(1):176-83. doi: 10.1016/j.yexmp.2009.11.004. Epub 2009 Nov 17.
PubMed 19931241de Camargo Cancela M, Voti L, Guerra-Yi M, Chapuis F, Mazuir M, Curado MP. Oral cavity cancer in developed and in developing countries: population-based incidence. Head Neck. 2010 Mar;32(3):357-67. doi: 10.1002/hed.21193.
PubMed 19644932Blache P, van de Wetering M, Duluc I, Domon C, Berta P, Freund JN, Clevers H, Jay P. SOX9 is an intestine crypt transcription factor, is regulated by the Wnt pathway, and represses the CDX2 and MUC2 genes. J Cell Biol. 2004 Jul 5;166(1):37-47. doi: 10.1083/jcb.200311021.
PubMed 15240568
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.
- ClinicalTrials.gov ID
- NCT01919567
- Acronym / sponsor ID
- 201012095RC
- Conditions
- Carcinogenesis, Oral Cancer
- Keywords
- SOX-9, Oral cancer, arecoline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 9 Aug 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.
Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.
Detailed description
To find out if there is prognostic value which to the performance of SOX-9 of oral cancer in Taiwan and provide some reference for future treatment.
We anticipate to enroll 40 persons with normal oral mucosa, 65 persons with oral dysplasia and 150 persons with oral cancer and collect the tissue which was stained for pathological sections over a 3 year period.
We also collect the blood and saliva samples from patients and the results along with patient-specific information such as tumor phases, tumor size, lymph node metastasis, cancer metastasis, prognosis and betel nut chewing, smoking and drinking habits and other parameters are statistically analyzed.
Study design
- Observational model
- Case-control
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal team | – | –Subjects who have problem at third molar of impacted tooth need to receive a surgery with general anesthesia. Subjects must: Should have a blood exam (20ml) before the surgery. Site staff must: Collect subjects' saliva once a day (in the morning before breakfast) for 3 consecutive days. Collect a 0.5x0.5Cm2 tissue sample around third molar during the surgery. |
| Oral dysplasia | – | –Subjects who are diagnosed with dysplasia of oral cavity. Subjects must: Should have a blood exam (20ml/each time) before the surgery and 3 months after the surgery. In the case the disease recurs after the surgery, subjects need to receive the surgery again and take another blood exam before the surgery and 3 months after the surgery. Before the surgery site staff must: Collect saliva once a day (in the morning before breakfast) for 3 consecutive days. Collect a 0.5x0.5Cm2 tissue sample of the tumor during the surgery. |
| Oral cancer | – | –Subjects who suffer from oral cancer. Subjects must: Should have a blood exam (20ml/each time) before the surgery and 3 months after the surgery. In the case the disease recurs after the surgery, subjects need to receive the surgery again and take another blood exam before the surgery and 3 months after the surgery. Before the surgery site staff must: Collect subjects' saliva once a day (in the morning before breakfast) for 3 consecutive days. Collect a 0.5x0.5Cm2 tissue sample of the tumor during the surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical center
Key inclusion criteria (1 listed)
- Dysplasia or cancer of the oral cavity.
Key exclusion criteria (1 listed)
- pregnant woman
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
Carcinogenesis of SOX-9
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Background: PubMed 12420222Afonja O, Raaka BM, Huang A, Das S, Zhao X, Helmer E, Juste D, Samuels HH. RAR agonists stimulate SOX9 gene expression in breast cancer cell lines: evidence for a role in retinoid-mediated growth inhibition. Oncogene. 2002 Nov 7;21(51):7850-60. doi: 10.1038/sj.onc.1205985.
- Background: PubMed 18087279Aleman A, Adrien L, Lopez-Serra L, Cordon-Cardo C, Esteller M, Belbin TJ, Sanchez-Carbayo M. Identification of DNA hypermethylation of SOX9 in association with bladder cancer progression using CpG microarrays. Br J Cancer. 2008 Jan 29;98(2):466-73. doi: 10.1038/sj.bjc.6604143. Epub 2007 Dec 18.
- Background: PubMed 19736325Alvarez-Medina R, Le Dreau G, Ros M, Marti E. Hedgehog activation is required upstream of Wnt signalling to control neural progenitor proliferation. Development. 2009 Oct;136(19):3301-9. doi: 10.1242/dev.041772.
- Background: PubMed 17409199Bien-Willner GA, Stankiewicz P, Lupski JR. SOX9cre1, a cis-acting regulatory element located 1.1 Mb upstream of SOX9, mediates its enhancement through the SHH pathway. Hum Mol Genet. 2007 May 15;16(10):1143-56. doi: 10.1093/hmg/ddm061. Epub 2007 Apr 4.
- Background: PubMed 19019766Lu B, Fang Y, Xu J, Wang L, Xu F, Xu E, Huang Q, Lai M. Analysis of SOX9 expression in colorectal cancer. Am J Clin Pathol. 2008 Dec;130(6):897-904. doi: 10.1309/AJCPW1W8GJBQGCNI.
- Background: PubMed 15077158Drivdahl R, Haugk KH, Sprenger CC, Nelson PS, Tennant MK, Plymate SR. Suppression of growth and tumorigenicity in the prostate tumor cell line M12 by overexpression of the transcription factor SOX9. Oncogene. 2004 Jun 3;23(26):4584-93. doi: 10.1038/sj.onc.1207603.
- Background: PubMed 18339840Wang H, Leav I, Ibaragi S, Wegner M, Hu GF, Lu ML, Balk SP, Yuan X. SOX9 is expressed in human fetal prostate epithelium and enhances prostate cancer invasion. Cancer Res. 2008 Mar 15;68(6):1625-30. doi: 10.1158/0008-5472.CAN-07-5915.
- Background: PubMed 15781631Jay P, Berta P, Blache P. Expression of the carcinoembryonic antigen gene is inhibited by SOX9 in human colon carcinoma cells. Cancer Res. 2005 Mar 15;65(6):2193-8. doi: 10.1158/0008-5472.CAN-04-1484.
- Background: PubMed 14684982Knower KC, Kelly S, Harley VR. Turning on the male--SRY, SOX9 and sex determination in mammals. Cytogenet Genome Res. 2003;101(3-4):185-98. doi: 10.1159/000074336.
- Background: PubMed 17922924Ishida K, Ito S, Wada N, Deguchi H, Hata T, Hosoda M, Nohno T. Nuclear localization of beta-catenin involved in precancerous change in oral leukoplakia. Mol Cancer. 2007 Oct 9;6:62. doi: 10.1186/1476-4598-6-62.
- Background: PubMed 9973626Mertin S, McDowall SG, Harley VR. The DNA-binding specificity of SOX9 and other SOX proteins. Nucleic Acids Res. 1999 Mar 1;27(5):1359-64. doi: 10.1093/nar/27.5.1359.
- Background: PubMed 10974408Murata M, Iwao K, Miyoshi Y, Nagasawa Y, Yabu M, Himeno S, Imanishi K, Ohsawa M, Wada H, Tominaga S, Shimano T, Kobayashi T, Nakamura Y. Activation of the beta-catenin gene by interstitial deletions involving exon 3 as an early event in colorectal tumorigenesis. Cancer Lett. 2000 Oct 16;159(1):73-8. doi: 10.1016/s0304-3835(00)00533-4.
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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.
Shin-Jung Cheng, DDS, MS, PhD principal investigator
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 Carcinogenesis and 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 10 Dec 2013. 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 Shin-Jung Cheng, DDS, MS, PhD (+886 2 29251733 ext. 67509, sjcheng56@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carcinogenesis of SOX-9 (time frame: 3 years). 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 NCT01919567, which also lists 21 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 10 Dec 2013.