Clinical trial NCT01774266: Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer
Official title: Screening and Triage Test for Early Detection of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Gastric Cancer
Keywords: Gastric Cancer
DNA methylation
Reprimo
cell-free DNA
non-invasive
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Ministerio de Salud de Chile
name: Hoffmann-La Roche
name: Red Salud UC
First posted: 2013-01-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.

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 criteria: Inclusion Criteria:

* Male or Female
* Age 40-70 y.o.

Exclusion Criteria:

* Gastric Cancer
* Dyspepsia
* Bleeding disorders

Primary outcomes:
measure: Early detection of gastric cancer
timeFrame: 2 years
Secondary outcomes:
measure: Monitoring progression of disease
timeFrame: 2 years
Other outcomes:
measure: Detection of H.pylori and gastric atrophy
timeFrame: 2 years
Locations:
city: Molina
country: Chile
facility: Hospital Santa Rosa de Molina
state: Region del Maule
Study officials:
References:
citation: Bernal C, Aguayo F, Villarroel C, Vargas M, Diaz I, Ossandon FJ, Santibanez 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.
citation: Carrasco G, Corvalan AH. Helicobacter pylori-Induced Chronic Gastritis and Assessing Risks for Gastric Cancer. Gastroenterol Res Pract. 2013;2013:393015. doi: 10.1155/2013/393015. Epub 2013 Jul 29.