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Trial record 2 of 58 for:    Stratify 1

Chilean Gastric Cancer Task Force (FORCE 1) (FORCE-1)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Pontificia Universidad Catolica de Chile
Sponsor:
Collaborators:
Center of Excellence of Precision Medicine (CEMP)
Advanced Center for Chronic Diseases (ACCDiS)
Millennium Institute on Immunology and Immunotherapy
Center UC for Investigation in Oncology (CITO)
Centre of Clinical Research, Health Technology Assessment Unit
National Scientific and Technical Research Council (CONICET), Argentina
Grupo Oncologico Cooperativo del Sur (GOCS), Argentina
Hospital Universitario central de Asurias, Oviedo, España
Hospital Morales Meseger, Murcia, España
Centro de Cancer. Pontificia Universidad Católica de Chile
Hematology and Oncology Department
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT03158571
First received: May 16, 2017
Last updated: May 17, 2017
Last verified: May 2017
  Purpose

Background. Gastric cancer (GC) is the world's second leading cause of neoplastic mortality. Genetic alterations, response to treatments and mortality rates are highly heterogeneous across different regions. In Chile, GC is the leading cause of cancer death, affecting 20 per 100,000 people and >3,000 deaths/year. Clinical outcomes and response to "one size fits all" therapies are highly heterogeneous and thus a better stratification of patients may aid cancer treatment and response.

Study design/methods. The Gastric Cancer Task Force (GCTF) is a Chilean collaborative, non-interventional retrospective study that seeks to stratify gastric adenocarcinomas (GACs) using retrospect clinical outcomes and genomic, epigenomic and protein alterations in a cohort of 200 patients. Tumor samples from the pathology department and the Cancer Center at UC Christus healthcare network at Pontificia Universidad Católica de Chile will be analyzed using a panel of 143 known cancer genes (Oncomine Comprehensive Assay) at the Center of Excellence of Precision Medicine (CEMP) in Santiago, Chile. Additionally, gene promoter methylation will be performed and selected clinically relevant proteins (e.g. PD-L1, Erb-2, VEGFR2 among others) will be assessed by Tissue Microarray, Epstein-Barr virus (EBV) status will also be assessed. Observations will be correlated to 120 clinical parameters, including general patient information, cancer history, laboratory studies, comorbidity index, chemotherapy, targeted therapies, efficacy and follow-up.

Discussion. The development of a clinically meaningful classification that encompasses comprehensive clinical and molecular parameters may improve patient treatment, predict clinical outcomes, aid patient selection for clinical trials and offer insights into future preventive and/or therapeutic strategies.


Condition
Biomarkers

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Chilean Gastric Cancer Task Force (FORCE 1): A Study Protocol to Obtain a Clinical and Molecular Classification of a Cohort of Gastric Cancer Patients.

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Overall survival [ Time Frame: two years ]
    Overall survival of patients with gastric cancer


Biospecimen Retention:   Samples With DNA
RNA and DNA

Estimated Enrollment: 200
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chilean population diagned with gastric cancer
Criteria

Inclusion Criteria:

  • Diagnosed with gastric cancer (histological or cytological) Attending health centers of the Red UC Christus network for at least 3 months with clinical follow-up.

Capable to read and speak spanish Willing and able to provide written informed consent to eh study that should be dated and signed informed consent

Exclusion Criteria:

  • With small biopsy samples insufficient for analysis. Whose medical records cannot be collected or are unavaible Without signed informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03158571

Contacts
Contact: Marcelo Garrido, MD 56223549034 mgarrido@med.puc.cl
Contact: Ignacio Retamal, PhD 56223549034 iretamalf@uc.cl

Locations
Chile
Pontificia Universidad Católica de Chile Recruiting
Santiago, Chile
Contact: Ignacio Retamal, PhD    56223549034    iretamalf@uc.cl   
Sub-Investigator: Gareth Owen, PhD         
Sub-Investigator: Alejandro Corvalán, MD         
Sub-Investigator: Ricardo Arminsén, PhD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Center of Excellence of Precision Medicine (CEMP)
Advanced Center for Chronic Diseases (ACCDiS)
Millennium Institute on Immunology and Immunotherapy
Center UC for Investigation in Oncology (CITO)
Centre of Clinical Research, Health Technology Assessment Unit
National Scientific and Technical Research Council (CONICET), Argentina
Grupo Oncologico Cooperativo del Sur (GOCS), Argentina
Hospital Universitario central de Asurias, Oviedo, España
Hospital Morales Meseger, Murcia, España
Centro de Cancer. Pontificia Universidad Católica de Chile
Hematology and Oncology Department
Investigators
Principal Investigator: Marcelo Garrido, MD Pontificia Universidad Catolica de Chile
  More Information

Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03158571     History of Changes
Other Study ID Numbers: GCTF1
Study First Received: May 16, 2017
Last Updated: May 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Public information of the data base

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pontificia Universidad Catolica de Chile:
Gastric Cancer
gastric adenocarcinoma
cancer subtypes
prognosis
survival
molecular classification
chemotherapy
immunotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 26, 2017