GICCA: GastroIntestinal Cancer in Children and Adolescents

Sponsor

Paul G. Kemps, MD (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05693519

Collaborator

Juliana Children's Hospital (Other)

2,500

Enrollment

Locations

Anticipated Duration (Months)

1250

Patients Per Site

209

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer Colorectal Cancer Gastric Cancer Hepatoblastoma Hepatocellular Carcinoma Burkitt Lymphoma Neuroendocrine Tumors

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 Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 22, 2022

Anticipated Primary Completion Date :

Jun 22, 2023

Anticipated Study Completion Date :

Jun 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Children Patients aged 0-17 years at primary gastrointestinal cancer diagnosis
Young people aged 18-24 years Patients aged 18-24 years at primary gastrointestinal cancer diagnosis

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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