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Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix (SurvivApp)

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ClinicalTrials.gov Identifier: NCT03852693
Recruitment Status : Not yet recruiting
First Posted : February 25, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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.


Condition or disease Intervention/treatment
Neuroendocrine Tumors of the Appendix Other: Histopathological review

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix: An International Multicenter Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Retrospective Group Other: Histopathological review
Histopathological review
Prospective Group Other: Histopathological review
Histopathological review


Outcome Measures
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Primary Outcome Measures :
  1. Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner [ Time Frame: 10 years ]
  2. Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner [ Time Frame: 10 years ]
  3. Frequency of distant metastases in aNET measuring 1-2 cm [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 10 years ]
  2. Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm [ Time Frame: 10 years ]
  3. Long-term survival after complete resection of aNET measuring 1 - 2 cm with or without oncological right-sided hemicolectomy [ Time Frame: 10 years ]

Biospecimen Retention:   Samples Without DNA
Tissue blocks of deceased or distant metastatic patients.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852693


Contacts
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Contact: Reto Kaderli, MD +41 31 632 23 26 reto.kaderli@insel.ch

Locations
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Switzerland
UHIBerne Enrolling by invitation
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Reto Kaderli, MD University Hospital Inselspital, Berne
More Information
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Additional Information:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03852693     History of Changes
Other Study ID Numbers: SurvivApp
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Appendiceal Neoplasms
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Cecal Neoplasms
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases