Oral CancermicroRNA-29bNCT02009852
The Role of microRNA-29b in the Oral Squamous Cell Carcinoma
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The Role of microRNA-29b in the Oral Squamous Cell Carcinoma Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2014
- How long will I take part?
- 3 Years
- 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
- Cancer of the oral cavity.
Who cannot join
- pregnant woman
- refuse the surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital research Ethics Committee
Taipei, 10048
Shin-Jung Cheng, 10048, +886 2 29251733 ext. 67509, sjcheng56@ntu.edu.tw
Shin-Jung Cheng, DDS, MS, PhD
About this study
The Role of microRNA-29b in the Oral Squamous Cell Carcinoma
Read the detailed description
To find out if there is prognostic value which to the performance of microRNA-29b of oral cancer in Taiwan and provide some reference for future treatment.
We anticipate to enroll 100 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
- Oral Cancer
- Keywords
- microRNA-29b, Oral squamous cell carcinoma, migration, prognosis
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
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 |
|---|---|---|
| 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.
microRNA-29b
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 posted12 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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 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 only
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
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
- NCT02009852
- Sponsor's protocol ID
- 201309076RIN
- Acronym
- microRNA-29b
- Status last verified
- Dec 2013
- First submitted
- 9 Dec 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ambros V. The functions of animal microRNAs. Nature. 2004 Sep 16;431(7006):350-5. doi: 10.1038/nature02871.
PubMed 15372042Fabbri M, Garzon R, Cimmino A, Liu Z, Zanesi N, Callegari E, Liu S, Alder H, Costinean S, Fernandez-Cymering C, Volinia S, Guler G, Morrison CD, Chan KK, Marcucci G, Calin GA, Huebner K, Croce CM. MicroRNA-29 family reverts aberrant methylation in lung cancer by targeting DNA methyltransferases 3A and 3B. Proc Natl Acad Sci U S A. 2007 Oct 2;104(40):15805-10. doi: 10.1073/pnas.0707628104. Epub 2007 Sep 21.
PubMed 17890317Pigazzi M, Manara E, Baron E, Basso G. miR-34b targets cyclic AMP-responsive element binding protein in acute myeloid leukemia. Cancer Res. 2009 Mar 15;69(6):2471-8. doi: 10.1158/0008-5472.CAN-08-3404. Epub 2009 Mar 3.
PubMed 19258499Ma L, Young J, Prabhala H, Pan E, Mestdagh P, Muth D, Teruya-Feldstein J, Reinhardt F, Onder TT, Valastyan S, Westermann F, Speleman F, Vandesompele J, Weinberg RA. miR-9, a MYC/MYCN-activated microRNA, regulates E-cadherin and cancer metastasis. Nat Cell Biol. 2010 Mar;12(3):247-56. doi: 10.1038/ncb2024. Epub 2010 Feb 21.
PubMed 20173740Ma L, Teruya-Feldstein J, Weinberg RA. Tumour invasion and metastasis initiated by microRNA-10b in breast cancer. Nature. 2007 Oct 11;449(7163):682-8. doi: 10.1038/nature06174. Epub 2007 Sep 26.
PubMed 17898713Huppi K, Volfovsky N, Mackiewicz M, Runfola T, Jones TL, Martin SE, Stephens R, Caplen NJ. MicroRNAs and genomic instability. Semin Cancer Biol. 2007 Feb;17(1):65-73. doi: 10.1016/j.semcancer.2006.10.004. Epub 2006 Oct 26.
PubMed 17113784Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. doi: 10.1056/NEJM199301213280306. No abstract available.
PubMed 8417385Fidler IJ. The pathogenesis of cancer metastasis: the 'seed and soil' hypothesis revisited. Nat Rev Cancer. 2003 Jun;3(6):453-8. doi: 10.1038/nrc1098.
PubMed 12778135Steeg PS. Tumor metastasis: mechanistic insights and clinical challenges. Nat Med. 2006 Aug;12(8):895-904. doi: 10.1038/nm1469. No abstract available.
PubMed 16892035Gupta GP, Massague J. Cancer metastasis: building a framework. Cell. 2006 Nov 17;127(4):679-95. doi: 10.1016/j.cell.2006.11.001.
PubMed 17110329Sciume G, Soriani A, Piccoli M, Frati L, Santoni A, Bernardini G. CX3CR1/CX3CL1 axis negatively controls glioma cell invasion and is modulated by transforming growth factor-beta1. Neuro Oncol. 2010 Jul;12(7):701-10. doi: 10.1093/neuonc/nop076. Epub 2010 Feb 8.
PubMed 20511186Kok SH, Hong CY, Lin SK, Lee JJ, Chiang CP, Kuo MY. Establishment and characterization of a tumorigenic cell line from areca quid and tobacco smoke-associated buccal carcinoma. Oral Oncol. 2007 Aug;43(7):639-47. doi: 10.1016/j.oraloncology.2006.07.007. Epub 2006 Oct 25.
PubMed 17070096Neville BW, Day TA. Oral cancer and precancerous lesions. CA Cancer J Clin. 2002 Jul-Aug;52(4):195-215. doi: 10.3322/canjclin.52.4.195.
PubMed 12139232Chang CC, Lin MT, Lin BR, Jeng YM, Chen ST, Chu CY, Chen RJ, Chang KJ, Yang PC, Kuo ML. Effect of connective tissue growth factor on hypoxia-inducible factor 1alpha degradation and tumor angiogenesis. J Natl Cancer Inst. 2006 Jul 19;98(14):984-95. doi: 10.1093/jnci/djj242.
PubMed 16849681Bartel DP. MicroRNAs: target recognition and regulatory functions. Cell. 2009 Jan 23;136(2):215-33. doi: 10.1016/j.cell.2009.01.002.
PubMed 19167326
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of microRNA-29b in the Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02009852
- Acronym / sponsor ID
- microRNA-29b / 201309076RIN
- Conditions
- Oral Cancer
- Keywords
- microRNA-29b, Oral squamous cell carcinoma, migration, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 12 Dec 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.
The Role of microRNA-29b in the Oral Squamous Cell Carcinoma
Detailed description
To find out if there is prognostic value which to the performance of microRNA-29b of oral cancer in Taiwan and provide some reference for future treatment.
We anticipate to enroll 100 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 only
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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)
- Cancer of the oral cavity.
Key exclusion criteria (2 listed)
- pregnant woman
- refuse the surgery
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
microRNA-29b
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 12 Dec 2013.
- Background: PubMed 15372042Ambros V. The functions of animal microRNAs. Nature. 2004 Sep 16;431(7006):350-5. doi: 10.1038/nature02871.
- Background: PubMed 17890317Fabbri M, Garzon R, Cimmino A, Liu Z, Zanesi N, Callegari E, Liu S, Alder H, Costinean S, Fernandez-Cymering C, Volinia S, Guler G, Morrison CD, Chan KK, Marcucci G, Calin GA, Huebner K, Croce CM. MicroRNA-29 family reverts aberrant methylation in lung cancer by targeting DNA methyltransferases 3A and 3B. Proc Natl Acad Sci U S A. 2007 Oct 2;104(40):15805-10. doi: 10.1073/pnas.0707628104. Epub 2007 Sep 21.
- Background: PubMed 19258499Pigazzi M, Manara E, Baron E, Basso G. miR-34b targets cyclic AMP-responsive element binding protein in acute myeloid leukemia. Cancer Res. 2009 Mar 15;69(6):2471-8. doi: 10.1158/0008-5472.CAN-08-3404. Epub 2009 Mar 3.
- Background: PubMed 20173740Ma L, Young J, Prabhala H, Pan E, Mestdagh P, Muth D, Teruya-Feldstein J, Reinhardt F, Onder TT, Valastyan S, Westermann F, Speleman F, Vandesompele J, Weinberg RA. miR-9, a MYC/MYCN-activated microRNA, regulates E-cadherin and cancer metastasis. Nat Cell Biol. 2010 Mar;12(3):247-56. doi: 10.1038/ncb2024. Epub 2010 Feb 21.
- Background: PubMed 17898713Ma L, Teruya-Feldstein J, Weinberg RA. Tumour invasion and metastasis initiated by microRNA-10b in breast cancer. Nature. 2007 Oct 11;449(7163):682-8. doi: 10.1038/nature06174. Epub 2007 Sep 26.
- Background: PubMed 17113784Huppi K, Volfovsky N, Mackiewicz M, Runfola T, Jones TL, Martin SE, Stephens R, Caplen NJ. MicroRNAs and genomic instability. Semin Cancer Biol. 2007 Feb;17(1):65-73. doi: 10.1016/j.semcancer.2006.10.004. Epub 2006 Oct 26.
- Background: PubMed 8417385Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. doi: 10.1056/NEJM199301213280306. No abstract available.
- Background: PubMed 12778135Fidler IJ. The pathogenesis of cancer metastasis: the 'seed and soil' hypothesis revisited. Nat Rev Cancer. 2003 Jun;3(6):453-8. doi: 10.1038/nrc1098.
- Background: PubMed 16892035Steeg PS. Tumor metastasis: mechanistic insights and clinical challenges. Nat Med. 2006 Aug;12(8):895-904. doi: 10.1038/nm1469. No abstract available.
- Background: PubMed 17110329Gupta GP, Massague J. Cancer metastasis: building a framework. Cell. 2006 Nov 17;127(4):679-95. doi: 10.1016/j.cell.2006.11.001.
- Background: PubMed 20511186Sciume G, Soriani A, Piccoli M, Frati L, Santoni A, Bernardini G. CX3CR1/CX3CL1 axis negatively controls glioma cell invasion and is modulated by transforming growth factor-beta1. Neuro Oncol. 2010 Jul;12(7):701-10. doi: 10.1093/neuonc/nop076. Epub 2010 Feb 8.
- Background: PubMed 17070096Kok SH, Hong CY, Lin SK, Lee JJ, Chiang CP, Kuo MY. Establishment and characterization of a tumorigenic cell line from areca quid and tobacco smoke-associated buccal carcinoma. Oral Oncol. 2007 Aug;43(7):639-47. doi: 10.1016/j.oraloncology.2006.07.007. Epub 2006 Oct 25.
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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 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 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: status not confirmed, as of the sponsor's last update on 12 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?
microRNA-29b (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 NCT02009852, which also lists 20 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 12 Dec 2013.