Chilean Gastric Cancer Task Force (FORCE 1)

NCT03158571 | Completed

• 1 other identifier: GCTF1
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biomarkers

Keywords

Gastric Cancer; gastric adenocarcinoma; cancer subtypes; prognosis; survival; molecular classification; chemotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival of patients with gastric cancer

  two years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chilean population diagned with gastric cancer

You may qualify if:

• 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

You may not qualify if:

• With small biopsy samples insufficient for analysis. Whose medical records cannot be collected or are unavaible Without signed informed consent.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Center of Excellence of Precision Medicine (CEMP): collaborator
• Advanced Center for Chronic Diseases (ACCDiS): collaborator
• Millennium Institute on Immunology and Immunotherapy: collaborator
• Center UC for Investigation in Oncology (CITO): collaborator
• Centre of Clinical Research, Health Technology Assessment Unit: collaborator
• National Scientific and Technical Research Council (CONICET), Argentina: collaborator
• Grupo Oncologico Cooperativo del Sur (GOCS), Argentina: collaborator
• Hospital Universitario central de Asurias, Oviedo, España: collaborator
• Hospital Morales Meseger, Murcia, España: collaborator
• Centro de Cancer. Pontificia Universidad Católica de Chile: collaborator
• Hematology and Oncology Department: collaborator

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Related Publications (2)

• Cordova-Delgado M, Pinto MP, Retamal IN, Munoz-Medel M, Bravo ML, Fernandez MF, Cisternas B, Mondaca S, Sanchez C, Galindo H, Nervi B, Ibanez C, Acevedo F, Madrid J, Pena J, Koch E, Maturana MJ, Romero D, de la Jara N, Torres J, Espinoza M, Balmaceda C, Liao Y, Li Z, Freire M, Garate-Calderon V, Caceres J, Sepulveda-Hermosilla G, Lizana R, Ramos L, Artigas R, Norero E, Crovari F, Armisen R, Corvalan AH, Owen GI, Garrido M. High Proportion of Potential Candidates for Immunotherapy in a Chilean Cohort of Gastric Cancer Patients: Results of the FORCE1 Study. Cancers (Basel). 2019 Aug 30;11(9):1275. doi: 10.3390/cancers11091275.

  PMID: 31480291 DERIVED

• Owen GI, Pinto MP, Retamal IN, Fernadez MF, Cisternas B, Mondaca S, Sanchez C, Galindo H, Nervi B, Ibanez C, Acevedo F, Madrid J, Pena J, Bravo ML, Maturana MJ, Cordova-Delgado M, Romero D, de la Jara N, Torres J, Rodriguez-Fernandez M, Espinoza M, Balmaceda C, Freire M, Garate-Calderon V, Crovari F, Jimenez-Fonseca P, Carmona-Bayonas A, Zwenger A, Armisen R, Corvalan AH, Garrido M. Chilean Gastric Cancer Task Force: A study protocol to obtain a clinical and molecular classification of a cohort of gastric cancer patients. Medicine (Baltimore). 2018 Apr;97(16):e0419. doi: 10.1097/MD.0000000000010419.

  PMID: 29668600 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

RNA and DNA

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Marcelo Garrido, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available within 6 months after study completion.
• Access Criteria: Access request will be reviewed by the principal investigator.

Locations

CL (1)