NCT05919758

Brief Summary

The goal of this observational study is to investigate the beneficial value of complementary surgery for appendiceal neuro-endocrine tumours in children. .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.7 years

First QC Date

May 8, 2023

Last Update Submit

July 29, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Overall survival rate

    cross-sectional design. follow-up will be done in 2023/2024

  • Complications directly related to primary and secondary treatment divided into major and minor complications according to Clavien-dindo.

    cross-sectional design. follow-up will be done in 2023/2024

  • Number of hospital readmission for complications related to treatment of NET

    cross-sectional design. follow-up will be done in 2023/2024

  • Length of hospital stay

    cross-sectional design. follow-up will be done in 2023/2024

  • number of imaging studies performed for follow-up of NET

    cross-sectional design. follow-up will be done in 2023/2024

  • +4 more secondary outcomes

Eligibility Criteria

AgeUp to 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All patients treated for an appendiceal neuro endocrine tumour before the age of 18 during 1990 and 2020

You may qualify if:

  • All patients that were treated for an appendiceal NET before the age of 18 years old
  • Time period: 1990-2020

You may not qualify if:

  • Other appendiceal malignancies/tumours, for example:
  • goblet cell carcinoma
  • adenocarcinoma
  • neuroendocrine carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam-Zuidoost, Netherlands

RECRUITING

MeSH Terms

Conditions

NeoplasmsAppendiceal Neoplasms

Condition Hierarchy (Ancestors)

Cecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Ramon R Gorter, MD PhD

    Amsterdam UMC, department of pediatric surgery

    STUDY CHAIR

Central Study Contacts

Ramon R Gorter, MD PhD

CONTACT

Martine F Raphael, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 8, 2023

First Posted

June 26, 2023

Study Start

May 1, 2023

Primary Completion

December 31, 2024

Study Completion

June 1, 2025

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

individual participant data will not be shared with other researchers. Collaborating institution will however enter participant data in a coded/pseudonimyzed manner in Castor EDC database.

Locations