Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer (DEMRAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Pontificia Universidad Catolica de Chile
Sponsor:
Collaborators:
Ministerio de Salud de Chile
Hoffmann-La Roche
Red Salud UC
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01774266
First received: January 19, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition
Early Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening and Triage Test for Early Detection of Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Early detection of gastric cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Increase the frequency of early detection rate of gastric cancer


Secondary Outcome Measures:
  • Monitoring progression of disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    In the case in which diagnoses of gastric cancer will be made, the result of treatment will be measure


Other Outcome Measures:
  • Detection of H.pylori and gastric atrophy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The rate of H.pylori detection and gastric atrophy based on serum levels of H.pylori and Pepsinogens I/II ratio.


Biospecimen Retention:   Samples With DNA

Blood and biopsy samples are collected


Estimated Enrollment: 3000
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Molina - Chile
Molina is one of the counties with the highest mortality rate of gastric cancer in Chile. Molina has a population of 40.000 hab mostly rural. Half of the population lives in Molina city and the other half in the suburbs. Molina is located near the Mountain Andes.

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

3000 population base study from rural area in south of Chile. This is area has one of the highest incidence of gastric cancer in the world (35/100.000).

Criteria

Inclusion Criteria:

  • Male or Female
  • Age 40-70 y.o.

Exclusion Criteria:

  • Gastric Cancer
  • Dyspepsia
  • Bleeding disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774266

Contacts
Contact: Alejandro H. Corvalan, M.D. +56-02-354-8289 corvalan@med.puc.cl

Locations
Chile
Hospital Santa Rosa de Molina Recruiting
Molina, Region del Maule, Chile, 8320000
Contact: Alejandro Corvalan, M.D.    56223548289    corvalan@med.puc.cl   
Contact: Paz Cook, R.N.    56223548289    pcook@gmail.com   
Principal Investigator: Mauricio Olivera, M.D.         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Ministerio de Salud de Chile
Hoffmann-La Roche
Red Salud UC
  More Information

Additional Information:
Publications:
Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01774266     History of Changes
Other Study ID Numbers: D09I1137, 11-156
Study First Received: January 19, 2013
Last Updated: May 30, 2013
Health Authority: Chile: Institutional Review Board

Keywords provided by Pontificia Universidad Catolica de Chile:
Gastric Cancer
DNA methylation
Reprimo
cell-free DNA
non-invasive

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 18, 2014