Neoplasms Clinical Trial
— NETkidsOfficial title:
The Value of Complementary Right-sided Hemicolectomy for Pediatric Patients With High-risk Neuroendocrine Tumors (NETs) of the Appendix; Towards the Development of an (Inter-) National Consensus Guideline for the Pediatric Population.
NCT number | NCT05919758 |
Other study ID # | W21_169#21.184 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | June 2025 |
The goal of this observational study is to investigate the beneficial value of complementary surgery for appendiceal neuro-endocrine tumours in children. .
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 17 Years |
Eligibility | Inclusion Criteria: - All patients that were treated for an appendiceal NET before the age of 18 years old - Time period: 1990-2020 Exclusion Criteria: - Other appendiceal malignancies/tumours, for example: - goblet cell carcinoma - adenocarcinoma - neuroendocrine carcinoma |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC | Amsterdam-Zuidoost |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival rate | defined as alive and free of recurrence of NET at telephone follow-up performed for this study purpose | cross-sectional design. follow-up will be done in 2023/2024 | |
Primary | Recurrence rate | defined as histopathologically proven metastasis/residual tumor at appendiceal stump of NET after a disease free period | cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | Overall survival rate | defined as alive at telephone follow-up performed for this study purpose | cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | Complications directly related to primary and secondary treatment divided into major and minor complications according to Clavien-dindo. | Complications include, but are not limited to:
Intra-abdominal abscess, defined as a radiologically confirmed accumulation of purulent fluid in a walled-off space within the abdominal cavity. (Adhesive) bowel obstruction requiring readmission (diagnosis based on clinical signs and symptoms such as a history of constipation, nausea, vomiting and distended abdomen) Superficial Surgical Site Infection, as defined by the CDC criteria. (see table 1.) Deep Surgical Site Infection, as defined by the CDC criteria. |
cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | Number of hospital readmission for complications related to treatment of NET | see title | cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | Length of hospital stay | initial and total length of stay | cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | number of imaging studies performed for follow-up of NET | ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), octreotide scintigraphy, PET-CT | cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | Number of outpatient check-ups(regular visits / telephone call) for follow-up of NET | see title | cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | Health related Quality of Life at follow-up moment for this study | measured by the PedsQL(generic) | cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | Health related Quality of Life at follow-up moment for this study | measured by the QLQ-C30(generic) | cross-sectional design. follow-up will be done in 2023/2024 | |
Secondary | Health related Quality of Life at follow-up moment for this study | measured by the QLQ-GINET-21 questionnaire(disease specific) | cross-sectional design. follow-up will be done in 2023/2024 |
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