Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America

Pancreatic Cancer Clinical Trial

— GASPAR  

Official title:

Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924789
• Other study ID #: LACOG0222
• Status: Recruiting
• Start date: August 11, 2023
• Est. completion date: June 17, 2024

Study information

• Verified date: March 2024
• Source: Latin American Cooperative Oncology Group
• Contact: Laura Mendonça Diefenthäeler
• Phone: +55 51 3384 5334
• Email: laura.mendonca[@]lacogcancerresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Currently, there is no Brazilian or Latin American epidemiological data, such as clinical-pathological characteristics, standard treatments and outcomes of gastric cancer and pancreatic cancer in the region. The study aims to create a Latin American multicenter database to analyze epidemiological, clinical, and pathological data, treatments, outcomes, and biological information from patients with gastric and pancreatic cancer.

Description:

Patients diagnosed with gastric and gastroesophageal junction or pancreatic cancer after January 2019 at participating sites will be included. Data will be collected from medical records in selected centers that comprise different countries from Latin America. Data collection will begin on the time of site activation. Patients recruited for this study will be identified in the participating sites. Data from clinical, demographic, and socioeconomic variables will be collected. Also, data on treatments performed and outcomes will be abstracted. The patient data sources will be the medical records of the patients. Patients will continue to receive treatment and clinical evaluations for gastric and gastroesophageal junction or pancreatic cancer according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 17, 2024
• Est. primary completion date: June 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years
• Histological diagnosis of gastric and gastroesophageal junction cancer (Cohort A) or histological diagnosis of pancreatic cancer (Cohort B);
• Advanced disease diagnosis from January 2019: patients can be included prospectively. Advanced disease is defined as metastatic disease or locally advanced disease not amenable to curative therapy;
• Availability of adequate medical data for data collection.

Exclusion Criteria:

• Synchronous invasive tumor or second primary tumor in the last three years (except thyroid tumors or non-melanoma skin);
• Nonepithelial histology in Cohort A: Sarcoma, GIST, lymphoma, and tumors of neuroendocrine origin;
• Nonepithelial histology in Cohort B: Sarcoma, GIST, lymphoma, pancreatoblastoma, and tumors of neuroendocrine origin.

Related Conditions & MeSH terms

• Gastric Cancer
• GastroEsophageal Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Observational study
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.

Locations

Country	Name	City	State
Argentina	Instituto de Oncología San Gerónimo	Santa Fe de la Vera Cruz	Santa Fé
Brazil	CEPON - Centro de Pesquisas Oncológicas	Florianópolis	Santa Catarina
Brazil	HMV - Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia	Salvador	Bahia
Brazil	A.C. Camargo Cancer Center	São Paulo
Brazil	BP - A Beneficência Portuguesa de São Paulo	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Astellas Pharma Inc, Grupo Argentino de Investigación Clínica en Oncología (GAICO)

Countries where clinical trial is conducted

Argentina,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the treatment patterns	Describe the treatment patterns and outcomes of patients with gastric and gastroesophageal junction cancer in Latin America.	During study duration (one year)