NCT01774266

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.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 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

September 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

January 19, 2013

Last Update Submit

May 30, 2013

Conditions

Keywords

Gastric CancerDNA methylationReprimocell-free DNAnon-invasive

Outcome Measures

Primary Outcomes (1)

  • Early detection of gastric cancer

    Increase the frequency of early detection rate of gastric cancer

    2 years

Secondary Outcomes (1)

  • Monitoring progression of disease

    2 years

Other Outcomes (1)

  • Detection of H.pylori and gastric atrophy

    2 years

Study Arms (1)

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.

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • Male or Female
  • Age 40-70 y.o.

You may not qualify if:

  • Gastric Cancer
  • Dyspepsia
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Santa Rosa de Molina

Molina, Maule Region, 8320000, Chile

RECRUITING

Related Publications (2)

  • 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.

    PMID: 18829507BACKGROUND
  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and biopsy samples are collected

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Alejandro H. Corvalan, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2013

First Posted

January 23, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2014

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations