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Clinical Trials/NCT05693519
NCT05693519
Active, not recruiting
Not Applicable

GastroIntestinal Cancer in Children and Adolescents (GICCA): a SEER Population-based Study

Paul G. Kemps, MD2 sites in 1 country2,500 target enrollmentDecember 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Cancer
Sponsor
Paul G. Kemps, MD
Enrollment
2500
Locations
2
Primary Endpoint
Overall survival
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

The goal of this observational population-based cohort study is to investigate the clinical characteristics and outcomes of children and adolescents with primary gastrointestinal malignancies registered in the publicly available Surveillance, Epidemiology, and End Results (SEER) 17 database during 2000-2019.

Detailed Description

The investigators aim to describe the patient and tumor characteristics, treatments, and outcomes of children and adolescents diagnosed with primary gastrointestinal malignancies, and to analyze these data for trends over time. In addition, the investigators want to explore independent prognostic factors for overall survival. Finally, the investigators want to describe subsequent primary malignancies diagnosed among patients from the study cohort, as well as to calculate their risk of developing a second primary cancer relative to the general population. Data on children (aged 0-17 years at diagnosis) and young people aged 18-24 years at diagnosis are analyzed separately. Special focus is laid on patients with primary carcinomas of the gastrointestinal tract; particularly colorectal carcinoma.

Registry
clinicaltrials.gov
Start Date
December 22, 2022
End Date
June 22, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Paul G. Kemps, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Paul G. Kemps, MD

Researcher

Leiden University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Age at primary gastrointestinal cancer diagnosis \<25 years
  • Diagnosis of a primary gastrointestinal malignancy as an individual's first primary malignancy

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Overall survival

Time Frame: 2000-2019

Defined as the time between the date of diagnosis and the date of death from any cause (event) or date of last follow-up.

Secondary Outcomes

  • Standardized incidence of second primary malignancies(2000-2019)

Study Sites (2)

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