NCT05924789

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 11, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

March 8, 2023

Last Update Submit

February 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Cohort A

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

Other: Observational study

Cohort B

80 patients histological diagnosis of pancreatic cancer.

Other: Observational study

Interventions

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

Cohort ACohort B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with gastric and gastroesophageal junction or pancreatic cancer after January 2019.

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Instituto de Oncología San Gerónimo

Santa Fe, Santa Fe Province, Argentina

Location

ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia

Salvador, Estado de Bahia, 41.950-640, Brazil

Location

HMV - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90.035-000, Brazil

Location

CEPON - Centro de Pesquisas Oncológicas

Florianópolis, Santa Catarina, 88.034-000, Brazil

Location

BP - A Beneficência Portuguesa de São Paulo

São Paulo, 01.323-030, Brazil

Location

A.C. Camargo Cancer Center

São Paulo, 01.509-001, Brazil

Location

MeSH Terms

Conditions

Stomach NeoplasmsPancreatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Renata D´Alpino Peixoto

    Latin American Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

June 29, 2023

Study Start

August 11, 2023

Primary Completion

September 24, 2024

Study Completion

September 24, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations