NCT03852693

Brief Summary

The aim of the present project is to evaluate the frequency of distant metastases and clinically relevant relapse and mortality, respectively, of aNEN (Neuroendocrine Neoplasms of the Appendix) measuring 1 - 2 cm. The investigators hypothesize that the mortality rate of aNET (Neuroendocrine Tumors of the Appendix) measuring 1 - 2cm is less than 1%. Furthermore, the investigators hypothesize that regional lymph node metastases of aNET measuring 1 - 2 cm are clinically not relevant and are not associated with reduced survival. The investigators therefore hypothesize that oncological right-sided hemicolectomy has no impact on long-term survival after complete resection of aNET measuring 1 - 2 cm and that the malignant potential quo ad vitam of these tumors is lower than the risk of oncological hemicolectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

February 20, 2019

Last Update Submit

November 11, 2024

Conditions

Neuroendocrine Tumors of the Appendix

Outcome Measures

Primary Outcomes (3)

  • Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner

    10 years

  • Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner

    10 years

  • Frequency of distant metastases in aNET measuring 1-2 cm

    10 years

Secondary Outcomes (3)

  • Association of histological risk factors in aNET measuring 1 - 2 cm and qualifying for oncological right-sided hemicolectomy according to ENETS guidelines with the occurrence of regional lymph node and distant metastases

    10 years

  • Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm

    10 years

  • Long-term survival after complete resection of aNET measuring 1 - 2 cm with or without oncological right-sided hemicolectomy

    10 years

Study Arms (2)

Retrospective Group

Other: Histopathological review

Prospective Group

Other: Histopathological review

Interventions

Histopathological reviewOTHER

Histopathological review

Prospective GroupRetrospective Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators will include all patients with aNET measuring 1 - 2 cm and complete resection between 01.01.2005 and 31.12.2010 of the primary tumor.

You may qualify if:

  • The investigators will include all patients with aNET measuring 1 - 2 cm and complete resection between 01.01.2005 and 31.12.2010 of the primary tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHIBerne

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Nesti C, Brautigam K, Benavent M, Bernal L, Boharoon H, Botling J, Bouroumeau A, Brcic I, Brunner M, Cadiot G, Camara M, Christ E, Clerici T, Clift AK, Clouston H, Cobianchi L, Cwikla JB, Daskalakis K, Frilling A, Garcia-Carbonero R, Grozinsky-Glasberg S, Hernando J, Hervieu V, Hofland J, Holmager P, Inzani F, Jann H, Jimenez-Fonseca P, Kacmaz E, Kaemmerer D, Kaltsas G, Klimacek B, Knigge U, Kolasinska-Cwikla A, Kolb W, Kos-Kudla B, Kunze CA, Landolfi S, La Rosa S, Lopez CL, Lorenz K, Matter M, Mazal P, Mestre-Alagarda C, Del Burgo PM, van Dijkum EJMN, Oleinikov K, Orci LA, Panzuto F, Pavel M, Perrier M, Reims HM, Rindi G, Rinke A, Rinzivillo M, Sagaert X, Satiroglu I, Selberherr A, Siebenhuner AR, Tesselaar MET, Thalhammer MJ, Thiis-Evensen E, Toumpanakis C, Vandamme T, van den Berg JG, Vanoli A, van Velthuysen MF, Verslype C, Vorburger SA, Lugli A, Ramage J, Zwahlen M, Perren A, Kaderli RM. Hemicolectomy versus appendectomy for patients with appendiceal neuroendocrine tumours 1-2 cm in size: a retrospective, Europe-wide, pooled cohort study. Lancet Oncol. 2023 Feb;24(2):187-194. doi: 10.1016/S1470-2045(22)00750-1. Epub 2023 Jan 11.

    PMID: 36640790DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue blocks of deceased or distant metastatic patients.

Study Officials

  • Reto Kaderli, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 25, 2019

Study Start

October 1, 2020

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)