Neuroendocrine Tumors of the Appendix Clinical Trial
— SurvivAppOfficial title:
Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix: An International Multicenter Study
| NCT number | NCT03852693 |
| Other study ID # | SurvivApp |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 1, 2020 |
| Est. completion date | April 1, 2022 |
| Verified date | August 2022 |
| Source | University Hospital Inselspital, Berne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 278 |
| Est. completion date | April 1, 2022 |
| Est. primary completion date | April 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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: - |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | UHIBerne | Bern |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Inselspital, Berne |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner | 10 years | ||
| Primary | Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner | 10 years | ||
| Primary | Frequency of distant metastases in aNET measuring 1-2 cm | 10 years | ||
| Secondary | 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 | ||
| Secondary | Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm | 10 years | ||
| Secondary | Long-term survival after complete resection of aNET measuring 1 - 2 cm with or without oncological right-sided hemicolectomy | 10 years |