Gastric CancerGASPARNCT05924789
Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America
An observational study of Gastric Cancer and GastroEsophageal Cancer, run by Latin American Cooperative Oncology Group at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, GastroEsophageal Cancer, Pancreatic Cancer
- What is being tested?
- Observational study
- How many people
- 120 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 11 Aug 2023to 24 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with gastric and gastroesophageal junction or pancreatic cancer after January 2019.
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Brazil5 sites
CEPON - Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, 88.034-000
HMV - Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90.035-000
ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
Salvador, Estado de Bahia, 41.950-640
BP - A Beneficência Portuguesa de São Paulo
São Paulo, 01.323-030
A.C. Camargo Cancer Center
São Paulo, 01.509-001
Argentina1 site
Instituto de Oncología San Gerónimo
Santa Fe, Santa Fe Province
About this study
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.
Read the 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.
- Conditions
- Gastric Cancer, GastroEsophageal Cancer, Pancreatic Cancer
- Being tested
- Observational study
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | 120 patients with histological diagnosis of gastric and gastroesophageal junction cancer. Receives: Other: Observational study | |
| Cohort B | 80 patients histological diagnosis of pancreatic cancer. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the treatment patterns
Describe the treatment patterns and outcomes of patients with gastric and gastroesophageal junction cancer in Latin America.
Measured: During study duration (one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start11 Aug 2023
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, Grupo Argentino de Investigación Clínica en Oncología (GAICO)
- Responsible party
- Sponsor
- Investigators
- Renata D´Alpino Peixoto, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924789
- Sponsor's protocol ID
- LACOG0222
- Acronym
- GASPAR
- Status last verified
- Feb 2025
- First submitted
- 8 Mar 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America
- ClinicalTrials.gov ID
- NCT05924789
- Acronym / sponsor ID
- GASPAR / LACOG0222
- Conditions
- Gastric Cancer, GastroEsophageal Cancer, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, Grupo Argentino de Investigación Clínica en Oncología (GAICO)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Observational study120 patients with histological diagnosis of gastric and gastroesophageal junction cancer. |
| Cohort B | – | Other: Observational study80 patients histological diagnosis of pancreatic cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with gastric and gastroesophageal junction or pancreatic cancer after January 2019.
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyThis is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. | Other | Cohort A, Cohort B |
Primary outcome
Describe the treatment patterns
Time frame: During study duration (one year)
Describe the treatment patterns and outcomes of patients with gastric and gastroesophageal junction cancer in Latin America.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata D´Alpino Peixoto principal investigator
Latin American Cooperative Oncology Group
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and GastroEsophageal Cancer, run by Latin American Cooperative Oncology Group at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the treatment patterns (time frame: During study duration (one year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.