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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02009852
Other study ID # 201309076RIN
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 9, 2013
Last updated December 9, 2013
Start date January 2014

Study information

Verified date December 2013
Source National Taiwan University Hospital
Contact Shin-Jung Cheng, DDS, MS, PhD
Phone +886 2 29251733
Email sjcheng56@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational [Patient Registry]

Clinical Trial Summary

The Role of microRNA-29b in the Oral Squamous Cell Carcinoma


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Cancer of the oral cavity.

Exclusion Criteria:

- pregnant woman

- refuse the surgery

Study Design

Observational Model: Case-Only


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital research Ethics Committee Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (20)

Ambros V. The functions of animal microRNAs. Nature. 2004 Sep 16;431(7006):350-5. Review. — View Citation

Bartel DP. MicroRNAs: target recognition and regulatory functions. Cell. 2009 Jan 23;136(2):215-33. doi: 10.1016/j.cell.2009.01.002. Review. — View Citation

Chang 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. — View Citation

Erreni M, Solinas G, Brescia P, Osti D, Zunino F, Colombo P, Destro A, Roncalli M, Mantovani A, Draghi R, Levi D, Rodriguez Y Baena R, Gaetani P, Pelicci G, Allavena P. Human glioblastoma tumours and neural cancer stem cells express the chemokine CX3CL1 and its receptor CX3CR1. Eur J Cancer. 2010 Dec;46(18):3383-92. doi: 10.1016/j.ejca.2010.07.022. Epub 2010 Aug 19. — View Citation

Fabbri 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. Epub 2007 Sep 21. — View Citation

Fidler IJ. The pathogenesis of cancer metastasis: the 'seed and soil' hypothesis revisited. Nat Rev Cancer. 2003 Jun;3(6):453-8. — View Citation

Gaudin F, Nasreddine S, Donnadieu AC, Emilie D, Combadière C, Prévot S, Machelon V, Balabanian K. Identification of the chemokine CX3CL1 as a new regulator of malignant cell proliferation in epithelial ovarian cancer. PLoS One. 2011;6(7):e21546. doi: 10.1371/journal.pone.0021546. Epub 2011 Jul 7. — View Citation

Gupta GP, Massagué J. Cancer metastasis: building a framework. Cell. 2006 Nov 17;127(4):679-95. Review. — View Citation

Huppi 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. Epub 2006 Oct 26. Review. — View Citation

Kok 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. Epub 2006 Oct 25. — View Citation

Ma 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. Epub 2007 Sep 26. Erratum in: Nature. 2008 Sep 11;455(7210):256. — View Citation

Ma 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. — View Citation

Moutasim KA, Jenei V, Sapienza K, Marsh D, Weinreb PH, Violette SM, Lewis MP, Marshall JF, Fortune F, Tilakaratne WM, Hart IR, Thomas GJ. Betel-derived alkaloid up-regulates keratinocyte alphavbeta6 integrin expression and promotes oral submucous fibrosis. J Pathol. 2011 Feb;223(3):366-77. doi: 10.1002/path.2786. Epub 2010 Oct 25. — View Citation

Neville BW, Day TA. Oral cancer and precancerous lesions. CA Cancer J Clin. 2002 Jul-Aug;52(4):195-215. Review. — View Citation

Pigazzi 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. — View Citation

Sciumè 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-ß1. Neuro Oncol. 2010 Jul;12(7):701-10. doi: 10.1093/neuonc/nop076. Epub 2010 Feb 8. — View Citation

Shiraishi K, Fukuda S, Mori T, Matsuda K, Yamaguchi T, Tanikawa C, Ogawa M, Nakamura Y, Arakawa H. Identification of fractalkine, a CX3C-type chemokine, as a direct target of p53. Cancer Res. 2000 Jul 15;60(14):3722-6. — View Citation

Steeg PS. Tumor metastasis: mechanistic insights and clinical challenges. Nat Med. 2006 Aug;12(8):895-904. Review. — View Citation

Thiery JP, Acloque H, Huang RY, Nieto MA. Epithelial-mesenchymal transitions in development and disease. Cell. 2009 Nov 25;139(5):871-90. doi: 10.1016/j.cell.2009.11.007. Review. — View Citation

Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. Review. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary microRNA-29b 3 years No
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