Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919758
Status:
RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-05-08
Brief Title:
Value of Right-sided Hemicolectomy for Chldren With High-risk Neuroendocrine Tumors of the Appendix
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NETkids
Brief Summary:
The goal of this observational study is to investigate the beneficial value of complementary surgery for appendiceal neuro-endocrine tumours in children
Detailed Description:
Aim Current guidelines recommend complementary right-sided hemicolectomy for high-risk pT2with risk factorspT3 neuro-endocrine tumors NET of the appendix based on adult studies In contrast to adults high-risk NET of the appendix in children seems to be a relatively benign disease with high disease-free survival 100 versus 70-80 in adults but high quality data are lacking Therefore these recommendations are now being questioned We aim to investigate the value of complementary right-sided hemicolectomy for children with high-risk NET of the appendix Ultimately leading to the development of a consensus guideline and solid information for patientsparents
Plan of investigation In order to generate big data an international historical cohort study is planned to compare complementary right-sided hemicolectomy with appendectomy alone for children with high-risk NET of the appendix Results will be CONFIDENTIAL used by an international expert group to formulate treatment recommendations Subsequently these recommendations will be tested in an international Delphi study in order to develop a consensus guideline on the treatment of pediatric high-risk NET of the appendix
Expected results The cohort study will generate high quality information on overalldisease-free survival recurrence complications costs and hr-QoL Recommendations made will be tested in a Delphi study not only on the beneficial value of complementary right-sided hemicolectomy but also on follow-up protocols and preoperative work-up Ultimately an international consensus guideline that redefines low-risk and high-risk NET of the appendix will be developed leading to global de-escalation and uniformity of treatment
Relevance for childhood cancer Results are relevant for pediatric oncologistssurgeonsgastro-enterologists across the world as redefining low-risk and high-risk patient groups will lead to de-escalation of treatment Furthermore QoL of child and parents can be improved by reducing exposure to complications after complementary right-sided hemicolectomy and by reducing the fear of recurrence by obtaining high-quality data to accurately inform patients and parents
Plan of investigation In order to generate big data an international historical cohort study is planned to compare complementary right-sided hemicolectomy with appendectomy alone for children with high-risk NET of the appendix Results will be CONFIDENTIAL used by an international expert group to formulate treatment recommendations Subsequently these recommendations will be tested in an international Delphi study in order to develop a consensus guideline on the treatment of pediatric high-risk NET of the appendix
Expected results The cohort study will generate high quality information on overalldisease-free survival recurrence complications costs and hr-QoL Recommendations made will be tested in a Delphi study not only on the beneficial value of complementary right-sided hemicolectomy but also on follow-up protocols and preoperative work-up Ultimately an international consensus guideline that redefines low-risk and high-risk NET of the appendix will be developed leading to global de-escalation and uniformity of treatment
Relevance for childhood cancer Results are relevant for pediatric oncologistssurgeonsgastro-enterologists across the world as redefining low-risk and high-risk patient groups will lead to de-escalation of treatment Furthermore QoL of child and parents can be improved by reducing exposure to complications after complementary right-sided hemicolectomy and by reducing the fear of recurrence by obtaining high-quality data to accurately inform patients and parents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None