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Trial Title:
Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America
NCT ID:
NCT05924789
Condition:
Gastric Cancer
GastroEsophageal Cancer
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Observational study
Description:
This is an observational study; patients will not be exposed to clinical interventions
different from those belonging to the standard of care.
Arm group label:
Cohort A
Arm group label:
Cohort B
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Patients diagnosed with gastric and gastroesophageal junction or pancreatic cancer after
January 2019.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto de Oncología San Gerónimo
Address:
City:
Santa Fe de la Vera Cruz
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Maria Gabriela Calafell
Email:
Principal Investigator
Facility:
Name:
ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
Address:
City:
Salvador
Zip:
41.950-640
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Anelisa Kruschewsky Coutinho Araujo
Email:
Principal Investigator
Facility:
Name:
HMV - Hospital Moinhos de Vento
Address:
City:
Porto Alegre
Zip:
90.035-000
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Rui Fernando Weschenfelder
Email:
Principal Investigator
Facility:
Name:
CEPON - Centro de Pesquisas Oncológicas
Address:
City:
Florianópolis
Zip:
88.034-000
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Victor Hugo Fonseca de Jesus
Email:
Principal Investigator
Facility:
Name:
BP - A Beneficência Portuguesa de São Paulo
Address:
City:
São Paulo
Zip:
01.323-030
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Antônio Soares Dias Junior
Email:
Principal Investigator
Facility:
Name:
A.C. Camargo Cancer Center
Address:
City:
São Paulo
Zip:
01.509-001
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Tiago Cordeiro Felismino
Email:
Principal Investigator
Start date:
August 11, 2023
Completion date:
September 23, 2024
Lead sponsor:
Agency:
Latin American Cooperative Oncology Group
Agency class:
Other
Collaborator:
Agency:
Astellas Pharma Inc
Agency class:
Industry
Collaborator:
Agency:
Grupo Argentino de Investigación Clínica en Oncología (GAICO)
Agency class:
Other
Source:
Latin American Cooperative Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05924789
