Cancer, Gastric Clinical Trial
— LEGACY-1Official title:
Gastric Cancer Risk Factors Associated With EU and CELAC Populations
NCT number | NCT03957031 |
Other study ID # | LEGACY-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2019 |
Est. completion date | December 31, 2023 |
Verified date | May 2024 |
Source | Fundación para la Investigación del Hospital Clínico de Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study uses a case-control design that examines the differences in types of exposures between cases defined with a pathological confirmation of GC diagnosis, and controls, defined as patients to whom a gastroscopy was indicated and confirmed absent of GC i
Status | Completed |
Enrollment | 1600 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Cases - Inclusion criteria - Subjects =18 years old. - GC diagnosis (including gastroesophageal junction cancer) from IPATIMUP, INCAN, VUMC, PUC, VHIO, IAF, INCLIVA and GENPAT centres, in the last six months before his/her inclusion in the study. - Has given and signed the IC to participate in this study. - Exclusion criteria: - Patients diagnosed with GC (including gastroesophageal junction cancer) from other centres/ countries not participating in this proposal. - Patients with suspected with GC diagnosis but not confirmed by the pathological report. Controls - Inclusion criteria - Subjects =18 years old. - Subjects to whom a gastroscopy was indicated in its medical care and confirmed absent of GC in the same centres will be matched in age (+/- 10 years), gender and pertaining from the same region of the GC case. Thus, to match our GC cases same number of controls is expected to be recruited. - Has given and signed the IC to participate in this study. - Exclusion criteria: - Subjects from a different geographic area from the cases. - Patients with high suspicion of GC (including gastroesophageal junction cancer) or previous personal history known of document chronic gastritis diagnosed by endoscopy and confirmed by histology. |
Country | Name | City | State |
---|---|---|---|
Argentina | Instituto Alexander Fleming | Buenos Aires | |
Chile | Pontificia Universidad Católica de Chile | Santiago | |
Mexico | Instituto Nacional de Cancerología | Mexico City | |
Netherlands | VU Medical Centre | Amsterdam | |
Paraguay | GenPat | Asunción | |
Portugal | Institute of Pathology and Immunology of University of Porto | Porto | |
Spain | Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO) | Barcelona | |
Spain | Hospital Clínico Universitario de Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Fundación para la Investigación del Hospital Clínico de Valencia | Amsterdam UMC, location VUmc, Hospital Central del IPS, INSTITUTO ALEXANDER FLEMING, Instituto Nacional de Cancerologia de Mexico, IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto, Pontificia Universidad Catolica de Chile, Vall d'Hebron Institute of Oncology |
Argentina, Chile, Mexico, Netherlands, Paraguay, Portugal, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exposure to a variety of potential sources of GC risk factors | The ratio of the odds of exposure vs. odds of no exposure to a variety of potential sources of GC risk factors in cases vs. controls. | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
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