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Screening and Triage Test for Early Detection of Gastric Cancer


N/A
40 Years
70 Years
Open (Enrolling)
Both
Early Gastric Cancer

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Trial Information

Screening and Triage Test for Early Detection of Gastric Cancer


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.


Inclusion Criteria:



- Male or Female

- Age 40-70 y.o.

Exclusion Criteria:

- Gastric Cancer

- Dyspepsia

- Bleeding disorders

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Early detection of gastric cancer

Outcome Description:

Increase the frequency of early detection rate of gastric cancer

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

Chile: Institutional Review Board

Study ID:

D09I1137

NCT ID:

NCT01774266

Start Date:

September 2012

Completion Date:

March 2014

Related Keywords:

  • Early Gastric Cancer
  • Gastric Cancer
  • DNA methylation
  • Reprimo
  • cell-free DNA
  • non-invasive
  • Stomach Neoplasms

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