Early Gastric CancerDEMRACNCT01774266
Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer
An observational study of Early Gastric Cancer, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Gastric Cancer
- How many people
- 3,000 participants
- Where
- 1 siteChile
- Study dates
- Sep 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Male or Female
- Age 40-70 y.o.
Who cannot join
- Gastric Cancer
- Dyspepsia
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Santa Rosa de Molina
Molina, Maule Region, 8320000
Alejandro Corvalan, M.D., 56223548289, corvalan@med.puc.cl
Paz Cook, R.N., 56223548289, pcook@gmail.com
About this study
Official title: Screening and Triage Test for Early Detection of Gastric Cancer
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.
Read the 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.
- Conditions
- Early Gastric Cancer
- Keywords
- Gastric Cancer, DNA methylation, Reprimo, cell-free DNA, non-invasive
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of gastric cancer
Increase the frequency of early detection rate of gastric cancer
Measured: 2 years
Secondary outcomes (1)
Monitoring progression of disease
In the case in which diagnoses of gastric cancer will be made, the result of treatment will be measure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Salud de Chile, Hoffmann-La Roche, Red Salud UC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774266
- Sponsor's protocol ID
- D09I1137
- Other IDs
- 11-156
- Acronym
- DEMRAC
- Status last verified
- May 2013
- First submitted
- 19 Jan 2013
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18829507Carrasco 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.
PubMed 23983680
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Triage Test for Early Detection of Gastric Cancer
- ClinicalTrials.gov ID
- NCT01774266
- Acronym / sponsor ID
- DEMRAC / D09I1137
- Conditions
- Early Gastric Cancer
- Keywords
- Gastric Cancer, DNA methylation, Reprimo, cell-free DNA, non-invasive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Ministerio de Salud de Chile, Hoffmann-La Roche, Red Salud UC
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2014 (estimated)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Male or Female
- Age 40-70 y.o.
Key exclusion criteria (3 listed)
- Gastric Cancer
- Dyspepsia
- Bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early detection of gastric cancer
Time frame: 2 years
Increase the frequency of early detection rate of gastric cancer
1 secondary outcome
Monitoring progression of disease
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
- Background: PubMed 18829507Bernal 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.
- Derived from this study: PubMed 23983680Carrasco 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.
- search for project D09I1137Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro H. Corvalan, M.D. (+56-02-354-8289, corvalan@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of gastric cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774266, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.