GASPAR: Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America

Sponsor
Latin American Cooperative Oncology Group (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05924789
Collaborator
Astellas Pharma Inc (Industry)
200
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational study

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.

No intervention is proposed in this study. Collection of archived samples of tumor tissue will not be performed in this study.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Cohort A

120 patients with histological diagnosis of gastric and gastroesophageal junction cancer.

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.

Cohort B

80 patients histological diagnosis of pancreatic cancer.

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.

Outcome Measures

Primary Outcome Measures

  1. Describe the treatment patterns [During study duration (one year)]

    Describe the treatment patterns and outcomes of patients with gastric and gastroesophageal junction cancer in Latin America.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Latin American Cooperative Oncology Group
  • Astellas Pharma Inc

Investigators

  • Principal Investigator: Renata D´Alpino Peixoto, Latin American Cooperative Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT05924789
Other Study ID Numbers:
  • LACOG0222
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2023