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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

Tracking Information
First Submitted Date February 20, 2019
First Posted Date February 25, 2019
Last Update Posted Date February 27, 2019
Estimated Study Start Date January 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2019)
  • 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 ]
Original Primary Outcome Measures
 (submitted: February 21, 2019)
  • Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner [ Time Frame: 1.5 years ]
  • Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner [ Time Frame: 1.5 years ]
  • Frequency of distant metastases in aNET measuring 1-2 cm [ Time Frame: 1.5 years ]
Change History Complete list of historical versions of study NCT03852693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 25, 2019)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: February 21, 2019)
  • 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: 1.5 years ]
  • Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm [ Time Frame: 1.5 years ]
  • Long-term survival after complete resection of aNET measuring 1 - 2 cm with or without oncological right-sided hemicolectomy [ Time Frame: 1.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix
Official Title Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix: An International Multicenter Study
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples Without DNA
Description:
Tissue blocks of deceased or distant metastatic patients.
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.
Condition Neuroendocrine Tumors of the Appendix
Intervention Other: Histopathological review
Histopathological review
Study Groups/Cohorts
  • Retrospective Group
    Intervention: Other: Histopathological review
  • Prospective Group
    Intervention: Other: Histopathological review
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 21, 2019)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Reto Kaderli, MD +41 31 632 23 26 reto.kaderli@insel.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03852693
Other Study ID Numbers SurvivApp
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators Not Provided
Investigators
Principal Investigator: Reto Kaderli, MD University Hospital Inselspital, Berne
PRS Account University Hospital Inselspital, Berne
Verification Date February 2019