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CarcinogenesisNCT01919580

Study on the Carcinogenesis of Gα12 in Oral Cancer, and the Treatment of Oral Cancer Using Ga12 Inhibitor.

An observational study of Carcinogenesis and Oral Cancer, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Study on the carcinogenesis of Gα12 in oral cancer, and chemopreventive possibility for the treatment of oral cancer using Ga12 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
Dec 2012to Jul 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.

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 Carcinogenesis of Gα12 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using Ga12 Inhibitor.

Study on the carcinogenesis of Gα12 in oral cancer, and chemopreventive possibility for the treatment of oral cancer using Ga12 inhibitor.

Read the detailed description

To find out if there is prognostic value which to the performance of Gα12 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.

Keywords
Gα12, Oral cancer
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 groups in NCT01919580
Study groupRoleWhat they receive
Normal teamSubjects 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 dysplasiaSubjects 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 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.
Oral cancerSubjects 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.

  1. Carcinogenesis of Gα12

    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 posted9 Aug 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionApr 2014
  4. Study completionJul 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
Case-control
Enrolment
255 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919580
Sponsor's protocol ID
201112057RIB
Status last verified
Apr 2014
First submitted
7 Aug 2013
Last updated
15 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Dolezalova H, Shankar G, Huang MC, Bikle DD, Goetzl EJ. Biochemical regulation of breast cancer cell expression of S1P2 (Edg-5) and S1P3 (Edg-3) G protein-coupled receptors for sphingosine 1-phosphate. J Cell Biochem. 2003 Mar 1;88(4):732-43. doi: 10.1002/jcb.10394.

    PubMed 12577307

  • Dorsam RT, Gutkind JS. G-protein-coupled receptors and cancer. Nat Rev Cancer. 2007 Feb;7(2):79-94. doi: 10.1038/nrc2069.

    PubMed 17251915

  • Etienne-Manneville S, Hall A. Rho GTPases in cell biology. Nature. 2002 Dec 12;420(6916):629-35. doi: 10.1038/nature01148.

    PubMed 12478284

  • Friedl P, Wolf K. Tumour-cell invasion and migration: diversity and escape mechanisms. Nat Rev Cancer. 2003 May;3(5):362-74. doi: 10.1038/nrc1075.

    PubMed 12724734

  • Gilman AG. G proteins: transducers of receptor-generated signals. Annu Rev Biochem. 1987;56:615-49. doi: 10.1146/annurev.bi.56.070187.003151. No abstract available.

    PubMed 3113327

  • Gohla A, Offermanns S, Wilkie TM, Schultz G. Differential involvement of Galpha12 and Galpha13 in receptor-mediated stress fiber formation. J Biol Chem. 1999 Jun 18;274(25):17901-7. doi: 10.1074/jbc.274.25.17901.

    PubMed 10364236

  • Gu JL, Muller S, Mancino V, Offermanns S, Simon MI. Interaction of G alpha(12) with G alpha(13) and G alpha(q) signaling pathways. Proc Natl Acad Sci U S A. 2002 Jul 9;99(14):9352-7. doi: 10.1073/pnas.102291599. Epub 2002 Jun 20.

    PubMed 12077299

  • Meigs TE, Fedor-Chaiken M, Kaplan DD, Brackenbury R, Casey PJ. Galpha12 and Galpha13 negatively regulate the adhesive functions of cadherin. J Biol Chem. 2002 Jul 5;277(27):24594-600. doi: 10.1074/jbc.M201984200. Epub 2002 Apr 25.

    PubMed 11976333

  • Moers A, Nurnberg A, Goebbels S, Wettschureck N, Offermanns S. Galpha12/Galpha13 deficiency causes localized overmigration of neurons in the developing cerebral and cerebellar cortices. Mol Cell Biol. 2008 Mar;28(5):1480-8. doi: 10.1128/MCB.00651-07. Epub 2007 Dec 17.

    PubMed 18086886

  • Parks S, Wieschaus E. The Drosophila gastrulation gene concertina encodes a G alpha-like protein. Cell. 1991 Jan 25;64(2):447-58. doi: 10.1016/0092-8674(91)90652-f.

    PubMed 1899050

  • Radeff-Huang J, Seasholtz TM, Matteo RG, Brown JH. G protein mediated signaling pathways in lysophospholipid induced cell proliferation and survival. J Cell Biochem. 2004 Aug 1;92(5):949-66. doi: 10.1002/jcb.20094.

    PubMed 15258918

  • Radhika V, Hee Ha J, Jayaraman M, Tsim ST, Dhanasekaran N. Mitogenic signaling by lysophosphatidic acid (LPA) involves Galpha12. Oncogene. 2005 Jun 30;24(28):4597-603. doi: 10.1038/sj.onc.1208665.

    PubMed 15856019

  • Xu J, Wang F, Van Keymeulen A, Herzmark P, Straight A, Kelly K, Takuwa Y, Sugimoto N, Mitchison T, Bourne HR. Divergent signals and cytoskeletal assemblies regulate self-organizing polarity in neutrophils. Cell. 2003 Jul 25;114(2):201-14. doi: 10.1016/s0092-8674(03)00555-5.

    PubMed 12887922

  • Yu YP, Landsittel D, Jing L, Nelson J, Ren B, Liu L, McDonald C, Thomas R, Dhir R, Finkelstein S, Michalopoulos G, Becich M, Luo JH. Gene expression alterations in prostate cancer predicting tumor aggression and preceding development of malignancy. J Clin Oncol. 2004 Jul 15;22(14):2790-9. doi: 10.1200/JCO.2004.05.158.

    PubMed 15254046

  • Buhl AM, Johnson NL, Dhanasekaran N, Johnson GL. G alpha 12 and G alpha 13 stimulate Rho-dependent stress fiber formation and focal adhesion assembly. J Biol Chem. 1995 Oct 20;270(42):24631-4. doi: 10.1074/jbc.270.42.24631.

    PubMed 7559569

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 15 Apr 2014. 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 Gα12 (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 NCT01919580, which also lists 16 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 15 Apr 2014.

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