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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05924789
Other study ID # LACOG0222
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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)
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