GastroIntestinal Cancer in Children and Adolescents (GICCA)

January 11, 2023 updated by: Paul G. Kemps, MD

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • South-Holland
      • Leiden, South-Holland, Netherlands, 2333ZA
        • Leiden University Medical Center
      • The Hague, South-Holland, Netherlands, 2545 AA
        • Juliana Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients aged 0-24 years with a diagnosis of a primary gastrointestinal malignancy as their first primary malignancy in the SEER 17 database from 2000 until (and including) 2019.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2000-2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized incidence of second primary malignancies
Time Frame: 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.
2000-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul G. Kemps, MD

Collaborators

Juliana Children's Hospital

Investigators

  • Principal Investigator: Paul G. Kemps, MD, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Anticipated)

June 22, 2023

Study Completion (Anticipated)

June 22, 2023

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nWMO-D4-2022-031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data are publicly available through SEER under the SEER Research Data Use Agreement.

IPD Sharing Time Frame

Supporting information is available on reasonable request.

IPD Sharing Access Criteria

When applicable, confidential information will be shared after a Data Transfer Agreement (DTA) has been signed by both parties.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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