NCT01919580

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

August 7, 2013

Last Update Submit

April 14, 2014

Conditions

Keywords

Gα12Oral cancer

Outcome Measures

Primary Outcomes (1)

  • Carcinogenesis of Gα12

    3 years

Study Arms (3)

Normal team

Subjects 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 dysplasia

Subjects 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 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.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Medical center

You may qualify if:

  • Dysplasia or cancer of the oral cavity.

You may not qualify if:

  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital research Ethics Committee

Taipei, 10048, Taiwan

RECRUITING

Related Publications (16)

  • 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.

    PMID: 12577307BACKGROUND
  • Dorsam RT, Gutkind JS. G-protein-coupled receptors and cancer. Nat Rev Cancer. 2007 Feb;7(2):79-94. doi: 10.1038/nrc2069.

    PMID: 17251915BACKGROUND
  • Etienne-Manneville S, Hall A. Rho GTPases in cell biology. Nature. 2002 Dec 12;420(6916):629-35. doi: 10.1038/nature01148.

    PMID: 12478284BACKGROUND
  • 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.

    PMID: 12724734BACKGROUND
  • 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.

    PMID: 3113327BACKGROUND
  • 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.

    PMID: 10364236BACKGROUND
  • 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.

    PMID: 12077299BACKGROUND
  • 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.

    PMID: 11976333BACKGROUND
  • 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.

    PMID: 18086886BACKGROUND
  • 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.

    PMID: 1899050BACKGROUND
  • 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.

    PMID: 15258918BACKGROUND
  • 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.

    PMID: 15856019BACKGROUND
  • 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.

    PMID: 12887922BACKGROUND
  • 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.

    PMID: 15254046BACKGROUND
  • 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.

  • Chan AM, Fleming TP, McGovern ES, Chedid M, Miki T, Aaronson SA. Expression cDNA cloning of a transforming gene encoding the wild-type G alpha 12 gene product. Mol Cell Biol. 1993 Feb;13(2):762-8. doi: 10.1128/mcb.13.2.762-768.1993.

Biospecimen

Retention: SAMPLES WITH DNA

tissue, serum, saliva

MeSH Terms

Conditions

CarcinogenesisMouth Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsHead and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Study Officials

  • Shin-Jung Cheng, DDS, MS, PhD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin-Jung Cheng, DDS, MS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 9, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations