GastroIntestinal Cancer in Children and Adolescents

Colorectal Cancer Clinical Trial

— GICCA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05693519
• Other study ID #: nWMO-D4-2022-031
• Status: Active, not recruiting
• Start date: December 22, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: January 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Colorectal Cancer
• Gastric Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Hepatoblastoma
• Hepatocellular Carcinoma
• Neuroendocrine Tumors

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	South-Holland
Netherlands	Juliana Children's Hospital	The Hague	South-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Paul G. Kemps, MD	Juliana Children's Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Defined as the time between the date of diagnosis and the date of death from any cause (event) or date of last follow-up.	2000-2019
Secondary	Standardized incidence of second primary malignancies	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.	2000-2019