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 :
Completed
First Posted : February 25, 2019
Last Update Posted : August 16, 2022
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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 Type : | Observational [Patient Registry] |
Actual Enrollment : | 278 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 |
Actual Study Start Date : | October 1, 2020 |
Actual Primary Completion Date : | April 1, 2022 |
Actual Study Completion Date : | April 1, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
Retrospective Group |
Other: Histopathological review
Histopathological review |
Prospective Group |
Other: Histopathological review
Histopathological review |
- Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner [ Time Frame: 10 years ]
- Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner [ Time Frame: 10 years ]
- Frequency of distant metastases in aNET measuring 1-2 cm [ Time Frame: 10 years ]
- 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 ]
- Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm [ Time Frame: 10 years ]
- 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

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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 |
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:
-

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
Switzerland | |
UHIBerne | |
Bern, Switzerland, 3010 |
Principal Investigator: | Reto Kaderli, MD | University Hospital Inselspital, Berne |
Responsible Party: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT03852693 |
Other Study ID Numbers: |
SurvivApp |
First Posted: | February 25, 2019 Key Record Dates |
Last Update Posted: | August 16, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |