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NCT01774266 Clinical Trial

Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer

Early Gastric Cancer Clinical Trial

— DEMRAC  

Official title:
Screening and Triage Test for Early Detection of Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01774266
Other study ID # D09I1137
Secondary ID 11-156
Status Recruiting
Phase N/A
First received January 19, 2013
Last updated May 30, 2013
Start date September 2012
Est. completion date March 2014

Study information
Verified date May 2013
Source Pontificia Universidad Catolica de Chile
Contact Alejandro H. Corvalan, M.D.
Phone +56-02-354-8289
Email corvalan@med.puc.cl
Is FDA regulated No
Health authority Chile: Institutional Review Board
Study type Observational

Clinical Trial Summary

In this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. This kit will be cost-effective and more accessible to the general population. In addition, the investigators would like to expand our current patent already submitted to INAPI (National Institute for Intellectual Property) and propose royalties to biomedical diagnostic companies for the use of our product at international level.

Description:

Gastric cancer is the first cause of death in Chile and the second worldwide. Currently, no screening methods are available for early detection of gastric cancer at population level. The only available test is serum levels of pepsinogen I/II for gastric atrophy, a precursor lesion only for intestinal type with low risk to progress to gastric cancer. The investigators' previous work, supported by FONDECYT (National Council for Research and Technology) and FONIS (National Council for Research and Development of Human Health) both from the Government of Chile led us to discover a potential biomarker for early detection of gastric cancer, Reprimo, a tumor suppressor gene related to p53 in the arrest of G2-M of the cell cycle (Clin Cancer Res. 2008;14:6264-9). Here, the investigators propose to evaluate plasmatic detection of Reprimo in conjunction with gastric atrophy markers and H.pylori detection to establish a novel screening and triage strategy for early detection of gastric cancer. The aims are i) to determine sensitivity and specificity for Reprimo in the detection of gastric cancer in a high-risk population evaluated by upper gastrointestinal endoscopy (1,000 males, 30-74 y.o. low income, symptomatic or asymptomatic) and ii) to characterize at clinical, pathological and molecular level cases of gastric cancer identified and non-identified by direct detection of Reprimo along with atrophy, H.pylori and clinical markers. With this information, the investigators will develop an algorithm for screening and triage evaluating predictive values of plasmatic detection of Reprimo versus atrophy & H.pylori detection and clinical data in a general population (3,000 male/female, 40-70 y.o.) from a high-risk area for gastric cancer in Chile. In this step the investigators will evaluate also acceptability, efficacy and efficiency of the proposed algorithm. In this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. This kit will be cost-effective and more accessible to the general population. In addition, the investigators would like to expand the investigators' current patent already submitted to INAPI and propose royalties to biomedical diagnostic companies for the use of the investigators' product at international level.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date March 2014
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Male or Female

- Age 40-70 y.o.

Exclusion Criteria:

- Gastric Cancer

- Dyspepsia

- Bleeding disorders

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Chile Hospital Santa Rosa de Molina Molina Region del Maule

Sponsors (4)
Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile Hoffmann-La Roche, Ministerio de Salud de Chile, Red Salud UC

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Bernal C, Aguayo F, Villarroel C, Vargas M, Díaz I, Ossandon FJ, Santibáñez E, Palma M, Aravena E, Barrientos C, Corvalan AH. Reprimo as a potential biomarker for early detection in gastric cancer. Clin Cancer Res. 2008 Oct 1;14(19):6264-9. doi: 10.1158/1078-0432.CCR-07-4522. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Detection of H.pylori and gastric atrophy The rate of H.pylori detection and gastric atrophy based on serum levels of H.pylori and Pepsinogens I/II ratio. 2 years No
Primary Early detection of gastric cancer Increase the frequency of early detection rate of gastric cancer 2 years No
Secondary Monitoring progression of disease In the case in which diagnoses of gastric cancer will be made, the result of treatment will be measure 2 years No
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