CClinicalTrials.gg
Status unknownNCT05693519GICCAUpdated Jan 23, 2023

GastroIntestinal Cancer in Children and Adolescents

An observational study in Gastrointestinal Cancer, Colorectal Cancer and Gastric Cancer, sponsored by Paul G. Kemps, MD. Status unknown at 2 sites in Netherlands. Open to participants aged 0 Years to 24 Years. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Paul G. Kemps, MD · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,500
Ages
0 Years to 24 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • SEER
  • Gastrointestinal
  • Cancer
  • Malignant
  • Child
  • Pediatric
  • Adolescent
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In context

Burkitt Lymphoma

392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 300 across 25 observational studies indexed under Burkitt Lymphoma.

Browse Burkitt Lymphoma studies →

Lead sponsor

This is the only study on the registry with Paul G. Kemps, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2000-2019

Secondary outcomes

  1. 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.

    Time frame: 2000-2019

07

Study locations

2 sites
  • Leiden University Medical Center
    Leiden, South-Holland 2333ZA, Netherlands
  • Juliana Children's Hospital
    The Hague, South-Holland 2545 AA, Netherlands
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 6, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data are publicly available through SEER under the SEER Research Data Use Agreement.

Supporting information: Study protocol, Sap, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05693519
Lead sponsor
Paul G. Kemps, MD
Collaborators
Juliana Children's Hospital
Responsible party
Paul G. Kemps, MD (Researcher, Leiden University Medical Center) — Sponsor-investigator
First posted
Jan 23, 2023
Start date
Dec 22, 2022
Primary completion
Jun 22, 2023 (estimated)
Completion
Jun 22, 2023 (estimated)
Last update
Jan 23, 2023

Study contacts

Paul G. Kemps, MD
principal investigator · Leiden University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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