GastroIntestinal Cancer in Children and Adolescents

NCT ID: NCT05693519

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-22

Study Completion Date

2023-06-22

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children

Patients aged 0-17 years at primary gastrointestinal cancer diagnosis

No interventions assigned to this group

Young people aged 18-24 years

Patients aged 18-24 years at primary gastrointestinal cancer diagnosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juliana Children's Hospital

UNKNOWN

Sponsor Role collaborator

Paul G. Kemps, MD

OTHER

Sponsor Role lead

Responsible Party

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Paul G. Kemps, MD

Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul G. Kemps, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status

Juliana Children's Hospital

The Hague, South Holland, Netherlands

Site Status

Countries

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Netherlands

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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nWMO-D4-2022-031

Identifier Type: -

Identifier Source: org_study_id

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