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

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ClinicalTrials.gov Identifier: NCT02009852
Recruitment Status : Unknown
Verified December 2013 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 12, 2013
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease
Oral Cancer

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 Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Target Follow-Up Duration: 3 Years
Official Title: The Role of microRNA-29b in the Oral Squamous Cell Carcinoma
Study Start Date : January 2014
Estimated Primary Completion Date : December 2014


Group/Cohort
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.




Primary Outcome Measures :
  1. microRNA-29b [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
tissue, serum, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Medical center
Criteria

Inclusion Criteria:

  • Cancer of the oral cavity.

Exclusion Criteria:

  • pregnant woman
  • refuse the surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009852


Contacts
Contact: Shin-Jung Cheng, DDS, MS, PhD +886 2 29251733 ext 67509 sjcheng56@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital research Ethics Committee Recruiting
Taipei, Taiwan, 10048
Contact: Shin-Jung Cheng, 10048    +886 2 29251733 ext 67509    sjcheng56@ntu.edu.tw   
Principal Investigator: Shin-Jung Cheng, DDS, MS, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shin-Jung Cheng, DDS, MS, PhD

Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02009852     History of Changes
Other Study ID Numbers: 201309076RIN
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by National Taiwan University Hospital:
microRNA-29b
Oral squamous cell carcinoma
migration
prognosis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases