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NeoplasmsNETkidsNCT05919758

Value of Right-sided Hemicolectomy for Chldren With High-risk Neuroendocrine Tumors of the Appendix

An observational study of Neoplasms and Appendix Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages Up to 17 years
Conditions the study is for
Neoplasms, Appendix Cancer
How many people
1,000 participants
Where
1 siteNetherlands
Study dates
1 May 2023to Jun 2025
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 Up to 17 years
  • All sexes
  • Child

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ramon R Gorter, MD PhD contact

0205669111

rr.gorter@amsterdamumc.nl

Martine F Raphael, MD PhD contact

0205669111

m.raphael@amsterdamumc.nl

Netherlands1 site, 1 recruiting

  • Amsterdam UMC

    Amsterdam-Zuidoost

    Ramon R Gorter, rr.gorter@amsterdamumc.nl

    Recruiting

Other trials in Netherlands

About this study

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.

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

.

Read the detailed description

Aim Current guidelines recommend complementary right-sided hemicolectomy for high-risk (pT2(with risk factors)/pT3) 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 patients/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 overall/disease-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 oncologists/surgeons/gastro-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.

Medical subject headings
Neoplasms, Appendiceal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival rate

    defined as alive and free of recurrence of NET at telephone follow-up performed for this study purpose

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

  2. Recurrence rate

    defined as histopathologically proven metastasis/residual tumor at appendiceal stump of NET after a disease free period

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

Secondary outcomes (9)

  1. Overall survival rate

    defined as alive at telephone follow-up performed for this study purpose

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

  2. 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.

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

  3. Number of hospital readmission for complications related to treatment of NET

    see title

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

  4. Length of hospital stay

    initial and total length of stay

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

  5. number of imaging studies performed for follow-up of NET

    ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), octreotide scintigraphy, PET-CT

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

  6. Number of outpatient check-ups(regular visits / telephone call) for follow-up of NET

    see title

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

  7. Health related Quality of Life at follow-up moment for this study

    measured by the PedsQL(generic)

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

  8. Health related Quality of Life at follow-up moment for this study

    measured by the QLQ-C30(generic)

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

  9. Health related Quality of Life at follow-up moment for this study

    measured by the QLQ-GINET-21 questionnaire(disease specific)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start1 May 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05919758
Sponsor's protocol ID
W21_169#21.184
Acronym
NETkids
Status last verified
Jul 2024
First submitted
8 May 2023
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms and Appendix Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site 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 4 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 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Ramon R Gorter, MD PhD (0205669111, rr.gorter@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival rate (time frame: cross-sectional design. follow-up will be done in 2023/2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05919758.

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 30 Jul 2024.

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