AzTrials
AzTrials

Head-and-Neck Squamous Cell CarcinomaNCT01927354

Study on the Interplay Between Twist1 and Other EMT Regulators Through microRNA-29 Family.

An observational study of Head-and-Neck Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Investigation of the molecular mechanism and clinical significance of the interplay between Twist1 and other EMT regulators through microRNA-29 family. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Head-and-Neck Squamous Cell Carcinoma
Type of treatment
Pill or oral medicine
How many people
100 participants
Where
1 siteTaiwan
Study dates
Dec 2012to Mar 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
  • No healthy volunteers
  • Adult, Older adult

Study population: Medical center

Who may be able to join

  • Head and neck cancer

Who cannot join

  • pregnant woman

Trial locations and contacts

1 site in 1 country.

Shin-Jung Cheng, DDS, MS, PhD contact

+886 2 29251733 ext. 67509

sjcheng56@ntu.edu.tw

Taiwan1 site, 1 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

    Recruiting

Other trials in Taiwan

About this study

Official title: Observational Study on the Investigation of the Molecular Mechanism and Clinical Significance of the Interplay Between Twist1 and Other EMT Regulators Through microRNA-29 Family.

Investigation of the molecular mechanism and clinical significance of the interplay between Twist1 and other EMT regulators through microRNA-29 family.

Read the detailed description

Head and neck squamous cell carcinoma (HNSCC) is one of the leading causes of cancer deaths worldwide, and it ranks the fourth male cancer-related death in Taiwan. In HNSCC, invasiveness and metastasis of cancer cells contribute to the major cause of mortality; therefore, elucidation of the mechanism and development of new strategies against metastasis is the utmost importance in treating advanced HNSCC. Epithelial-mesenchymal transition (EMT) is a process by which epithelial cells lose their polarity and are converted to a mesenchymal phenotype, and recently is considered as the major mechanism for cancer metastasis. The initiation of EMT is hallmarked by suppression of the intercellular junctional protein E-cadherin by a variety of transcriptional factors, including Twist1, Snail, Slug, SIP1, Zeb1 and E47. However, during metastatic evolution, the interplay between different EMT inducers has been investigated limitedly. Previously study demonstrated that hypoxia induces EMT of HNSCC through induction of Twist1 expression. Additionally showed that Twist1 promotes EMT and tumor-initiating capability through upregulation of Bmi1, and co-expression Twist1 and Bmi1 predicts a worse prognosis of HNSCC cases. Accumulated evidence suggests that microRNAs play essential roles in cancer progression and metastasis. Therefore, we aim to investigate the role of microRNA in Twist1-mediated cancer metastasis, and the interplay between Twist1 and other EMT regulators. Our preliminary data showed that the expression of miR-29 family, including miR-29a, b, and c were increased in Twist1-overexpressing HNSCC cells. Furthermore, we discovered that SIN3A, a co-repressor of another EMT regulator Snail, is a target of miR-29s. We therefore speculate that Twist1 modifies the function of Snail through microRNA machinery. In this proposal, we will delineate the regulatory mechanism of the Twist1-miR29s-SIN3A axis. We will also investigate the molecular interplay between Twist1 and Snail through Twist1-miR29s-SIN3A signal pathway. Furthermore, we will elucidate the molecular basis and pathophysiologic significance of Twist1-Snail interaction under hypoxic environment. Finally, we will confirm the in vitro finding by in vivo animal study and HNSCC samples. These results will provide crucial information for understanding the molecular basis of HNSCC metastasis, and will be valuable for developing new therapeutic strategies against advanced HNSCC.

Keywords
Head-and-Neck squamous cell carcinoma (HNSCC), epithelial-mesenchymal transition (EMT), microRNA29, Twist1
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Acrocephalosyndactylia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01927354
Study groupRoleWhat they receive
Head and neck cancerSubjects who suffer from oral cancer. 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.

  1. The interplay between Twist1 and other EMT regulators throigh microRNA-29 family

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionMar 2014 (estimated)
  4. Study completionMar 2014 (estimated)

Resources

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
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01927354
Sponsor's protocol ID
201112085RID
Status last verified
Sep 2013
First submitted
7 Aug 2013
Last updated
16 Sep 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Department of health, the Executive Yuan, R.O.C. Cancer Registry Annual Report in Taiwan area, 2007. Goldenberg D, Lee J, Koch WM, et al.

  • Goldenberg D, Lee J, Koch WM, Kim MM, Trink B, Sidransky D, Moon CS. Habitual risk factors for head and neck cancer. Otolaryngol Head Neck Surg. 2004 Dec;131(6):986-93. doi: 10.1016/j.otohns.2004.02.035.

    PubMed 15577802

  • Haffty BG. Concurrent chemoradiation in the treatment of head and neck cancer. Hematol Oncol Clin North Am. 1999 Aug;13(4):719-42, vi-vii. doi: 10.1016/s0889-8588(05)70088-5.

    PubMed 10494509

  • Gilbert J, Forastiere AA. Organ preservation trials for laryngeal cancer. Otolaryngol Clin North Am. 2002 Oct;35(5):1035-54, vi. doi: 10.1016/s0030-6665(02)00035-x.

    PubMed 12587246

  • Fanucchi M, Khuri FR. Chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck. Semin Oncol. 2004 Dec;31(6):809-15. doi: 10.1053/j.seminoncol.2004.09.014.

    PubMed 15599859

  • Papadimitrakopoulou VA, Izzo J, Mao L, Keck J, Hamilton D, Shin DM, El-Naggar A, den Hollander P, Liu D, Hittelman WN, Hong WK. Cyclin D1 and p16 alterations in advanced premalignant lesions of the upper aerodigestive tract: role in response to chemoprevention and cancer development. Clin Cancer Res. 2001 Oct;7(10):3127-34.

    PubMed 11595705

  • Farrar M, Sandison A, Peston D, Gailani M. Immunocytochemical analysis of AE1/AE3, CK 14, Ki-67 and p53 expression in benign, premalignant and malignant oral tissue to establish putative markers for progression of oral carcinoma. Br J Biomed Sci. 2004;61(3):117-24. doi: 10.1080/09674845.2004.11732655.

    PubMed 15462255

  • Gold KA, Lee HY, Kim ES. Targeted therapies in squamous cell carcinoma of the head and neck. Cancer. 2009 Mar 1;115(5):922-35. doi: 10.1002/cncr.24123.

    PubMed 19156911

  • Nathan CO, Amirghahari N, Abreo F, Rong X, Caldito G, Jones ML, Zhou H, Smith M, Kimberly D, Glass J. Overexpressed eIF4E is functionally active in surgical margins of head and neck cancer patients via activation of the Akt/mammalian target of rapamycin pathway. Clin Cancer Res. 2004 Sep 1;10(17):5820-7. doi: 10.1158/1078-0432.CCR-03-0483.

    PubMed 15355912

  • Nakayama H, Ikebe T, Beppu M, Shirasuna K. High expression levels of nuclear factor kappaB, IkappaB kinase alpha and Akt kinase in squamous cell carcinoma of the oral cavity. Cancer. 2001 Dec 15;92(12):3037-44. doi: 10.1002/1097-0142(20011215)92:123.0.co;2-#.

    PubMed 11753981

  • Thiery JP. Epithelial-mesenchymal transitions in tumour progression. Nat Rev Cancer. 2002 Jun;2(6):442-54. doi: 10.1038/nrc822. No abstract available.

    PubMed 12189386

  • Higgins DF, Kimura K, Bernhardt WM, Shrimanker N, Akai Y, Hohenstein B, Saito Y, Johnson RS, Kretzler M, Cohen CD, Eckardt KU, Iwano M, Haase VH. Hypoxia promotes fibrogenesis in vivo via HIF-1 stimulation of epithelial-to-mesenchymal transition. J Clin Invest. 2007 Dec;117(12):3810-20. doi: 10.1172/JCI30487.

    PubMed 18037992

  • Thompson EW, Newgreen DF, Tarin D. Carcinoma invasion and metastasis: a role for epithelial-mesenchymal transition? Cancer Res. 2005 Jul 15;65(14):5991-5; discussion 5995. doi: 10.1158/0008-5472.CAN-05-0616. No abstract available.

    PubMed 16024595

  • Thiery JP, Sleeman JP. Complex networks orchestrate epithelial-mesenchymal transitions. Nat Rev Mol Cell Biol. 2006 Feb;7(2):131-42. doi: 10.1038/nrm1835.

    PubMed 16493418

  • Tamura G, Yin J, Wang S, Fleisher AS, Zou T, Abraham JM, Kong D, Smolinski KN, Wilson KT, James SP, Silverberg SG, Nishizuka S, Terashima M, Motoyama T, Meltzer SJ. E-Cadherin gene promoter hypermethylation in primary human gastric carcinomas. J Natl Cancer Inst. 2000 Apr 5;92(7):569-73. doi: 10.1093/jnci/92.7.569.

    PubMed 10749913

Questions about this trial

What is this clinical trial studying?

An observational study of Head-and-Neck Squamous Cell Carcinoma, 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 16 Sep 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?

The interplay between Twist1 and other EMT regulators throigh microRNA-29 family (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 NCT01927354, which also lists 51 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 16 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in