Clinical trial NCT05924789: Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America
Official title: Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
GastroEsophageal Cancer
Pancreatic Cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
name: Grupo Argentino de Investigación Clínica en Oncología (GAICO)
First posted: 2023-06-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with gastric and gastroesophageal junction or pancreatic cancer after January 2019.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Describe the treatment patterns
timeFrame: During study duration (one year)
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Fe de la Vera Cruz
country: Argentina
facility: Instituto de Oncología San Gerónimo
state: Santa Fé
city: Salvador
country: Brazil
facility: ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
state: Bahia
city: Porto Alegre
country: Brazil
facility: HMV - Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncológicas
state: Santa Catarina
city: São Paulo
country: Brazil
facility: BP - A Beneficência Portuguesa de São Paulo
city: São Paulo
country: Brazil
facility: A.C. Camargo Cancer Center
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Renata D´Alpino Peixoto
role: PRINCIPAL_INVESTIGATOR
References: