GastroIntestinal Cancer in Children and Adolescents

Active, not recruiting

• Conditions: Burkitt Lymphoma; Gastric Cancer; Hepatoblastoma; Neuroendocrine Tumors; Colorectal Cancer; Gastrointestinal Cancer; Hepatocellular Carcinoma

• Registration Number: NCT05693519
• Lead Sponsor: Paul G. Kemps, MD

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.

Study Timeline

• Study Start: 2022-12-22
• Study First Submitted: 2022-12-22
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-23
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2500

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	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 Outcome Measures

Name	Time	Method
Standardized incidence of second primary malignancies	2000-2019	Standardized incidence of second primary malignancies in patients who survived (i) two or more months, or (ii) five or more years after initial gastrointestinal cancer diagnosis, relative to the general population.

Trial Locations

Locations (2)

Leiden University Medical Center; 🇳🇱 Leiden, South-Holland, Netherlands

Juliana Children's Hospital; 🇳🇱 The Hague, South-Holland, Netherlands