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| Name | Class |
|---|---|
| Juliana Children's Hospital | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Paul G. Kemps, MD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands | ||
| Juliana Children's Hospital |
Data are publicly available through SEER under the SEER Research Data Use Agreement.
Supporting information is available on reasonable request.
When applicable, confidential information will be shared after a Data Transfer Agreement (DTA) has been signed by both parties.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2022 | Dec 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D018197 | Hepatoblastoma |
| D006528 | Carcinoma, Hepatocellular |
| D002051 | Burkitt Lymphoma |
| D018358 | Neuroendocrine Tumors |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| The Hague |
| South Holland |
| 2545 AA |
| Netherlands |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |