Gastrointestinal CancerGICCANCT05693519
GastroIntestinal Cancer in Children and Adolescents
An observational study of Gastrointestinal Cancer and Colorectal Cancer, run by Paul G. Kemps, MD at 2 sites in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 0 to 24 years
- Conditions the study is for
- Gastrointestinal Cancer, Colorectal Cancer, Gastric Cancer
- How many people
- 2,500 participants
- Where
- 2 sitesNetherlands
- Study dates
- 22 Dec 2022to 22 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Age at primary gastrointestinal cancer diagnosis <25 years
- Diagnosis of a primary gastrointestinal malignancy as an individual's first primary malignancy
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Juliana Children's Hospital
The Hague, South Holland, 2545 AA
About this study
Official title: 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.
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.
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Gastric Cancer, Hepatoblastoma, Hepatocellular Carcinoma, Burkitt Lymphoma
- Keywords
- SEER, Gastrointestinal, Cancer, Malignant, Child, Pediatric, Adolescent
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Hepatoblastoma, Carcinoma, Hepatocellular, Burkitt Lymphoma, Neuroendocrine Tumors, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2000-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start22 Dec 2022
- Primary completion22 Jun 2023 (estimated)
- Study completion22 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul G. Kemps, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Juliana Children's Hospital
- Responsible party
- Sponsor-investigator, Paul G. Kemps, MD, Leiden University Medical Center
- Investigators
- Paul G. Kemps, MD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693519
- Sponsor's protocol ID
- nWMO-D4-2022-031
- Acronym
- GICCA
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are publicly available through SEER under the SEER Research Data Use Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GastroIntestinal Cancer in Children and Adolescents (GICCA): a SEER Population-based Study
- ClinicalTrials.gov ID
- NCT05693519
- Acronym / sponsor ID
- GICCA / nWMO-D4-2022-031
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Gastric Cancer, Hepatoblastoma, Hepatocellular Carcinoma, Burkitt Lymphoma
- Keywords
- SEER, Gastrointestinal, Cancer, Malignant, Child, Pediatric, Adolescent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Paul G. Kemps, MDUniversity, hospital or other
- Collaborators
- Juliana Children's Hospital
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Jun 2023 (estimated)
- Study completion
- 22 Jun 2023 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Age at primary gastrointestinal cancer diagnosis <25 years
- Diagnosis of a primary gastrointestinal malignancy as an individual's first primary malignancy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Standardized incidence of second primary malignancies
Time frame: 2000-2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: Yes. Data are publicly available through SEER under the SEER Research Data Use Agreement.
Related trials for Gastrointestinal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul G. Kemps, MD principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer and Colorectal Cancer, run by Paul G. Kemps, MD at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2000-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.