Scientific DB projects

Levels 1 and 2 database projects

Level 1 and 2 database studies address scientific questions that can be answered by the existing database.

Who qualifies for database queries (levels 1 and 2)

  • Continuous and significant database contribution is the key
  • A study proposal with synopsis and publication concept is always required
  • Call for participation sent by the ENETS to each center

Are there any fees for database queries (levels 1 and 2)?

  • Feasibility evaluations of ENETS DB level 1 – no fee will be charged
  • Studies and queries of ENETS DB level 2 by data reporter:
    • No fee will be charged if the data reporter query can be completed by authorised ENETS staff
    • If KKS or other external support is required, a fee will be charged/a budget must be set up.

Level 2 projects

Retrospective VIPoma - Level 2 project

Treatment and outcome of VIPoma – A retrospective analysis of the ENETS database

Level: 2

Launch date: 1. quarter of 2023

Principle investigator: Detlef BARTSCH

Project description:

Background: VIPoma is an extremely rare functional neuroendocrine pancreatic neoplasia, (incidence <1/1000.000/year), which typically causes watery diarrhea by a secretory excess of vasoactive intestinal polypeptide (1). The cornerstone of treatment is complete tumor resection, whenever possible. Since VIPomas have a high potential to metastasize, however, curative resection is not possible in a significant proportion of patients. There is a lack of data regarding treatment and outcome of these tumors, since only small case series of up to 15 patients have been published (2, 3).

Aim: Retrospective data analysis of patients with histologically proven VIPoma regarding demographics, present syndrome, stage at diagnosis, surgical and non-surgical treatments as well as prognosis.  

Inclusion criteria: Patients with histologically proven VIPoma who were treated from 1.07.2012 until 31.03. 2022 at NEN referral centers. Patients‘ informed consent to be documented in the ENETS database. Written consent of participating centers to participate in this retrospective study. The local responsible investigator has to be determined beforehand.

Methods: Anonymized patients with VIPoma will be captured in the extended data set (level II) of the ENETS-DB by participating centers until 31.03.2023. No additional items will be programmed, but the items of the extended data set should be completed as far as ever possible. The data will be extracted, analysed and statistical analyses performed by a statistician of the Marburg team until 30.06.2023. Thereafter it is planned to prepare a publication and submit it under the ENETS umbrella after been consented by all participants.

Publication rules: Every participating institution will have 1 (co)-authorship, further participating persons of the same institution will be listed in the acknowledgement. If the number of co-authors has to be limited to a journals policy, the order will be determined according to the patient numbers recruited. The PI of the best recruiting institution will be first author, the statistician second author, the order of the other co-authors will be according to the number of patients enrolled. D. Bartsch of the Marburg group, who coordinates the study, will be senior author.  

Study costs: 500-1000€ for the statistical analysis, may be covered by D.B.

Funding: no funding applied for

References:

  1. Falconi M, et al. ENETS Consensus Guidelines Update for the management of patients with functional pancreatic neuroendocrine tumors and non-functional pancreatic neuroendocrine tumors. Neuroendocrinology. 2016;103:153-171.
  2. Angelousi A, et al. Diagnostic and management challenges in vasoactive intestinal peptide secreting tumors: a series of 15 patients. Pancreas 2019; 48: 934-942.
  3. Peng SY, et al. Diagnosis and treatment of VIPoma in China (case report and 31 cases literature review). Pancreas 004; 28: 93-97.

Level 3 database projects

Level 3 database studies address scientific questions which cannot answered by the existing database. These require extra programming.

Who qualifies for level 3 database projects?

  • Authorised ENETS task forces and Centres of Excellence DB participants
  • A study synopsis and proposal including publication policy is required
  • A separate ethic committee approval might be necessary/must be determined
  • Funding must be secured
  • Proposals will be evaluated in the spirit of goodwill by the DB review and support board
  • Call for participation and agreement to participate sent by ENETS to each center
  • Separate contract with KKS is necessary

Level 3 projects

CHD - Level 3 project

Multi-parametric risk assessment of patients with Carcinoid Heart Disease - A project of the ENETS CHD Task Force

Level: 3

Launch date: 1. quarter of 2023

Task force chairs: Simona GLASBERG & Joseph DAVAR

Principle investigators: Joseph DAVAR & Sanjeev BHATTACHARYYA

Project description:

This study is organized by the ENETS CHD Task Force and aims to develop a risk-of-death score combining clinical, echocardiographic, and biochemical markers to risk stratify patients with carcinoid heart disease to help determine appropriate therapy.

All data will be retrospectively collected from ENETS multidisciplinary centers and centers specialized in the field, to guarantee quality data.

The primary outcome measure will be overall survival (regardless of cause of death).

T0 will be defined as the date from diagnosis of severe carcinoid heart disease. Survival will be defined as date of diagnosis of carcinoid heart disease to date of death (or last follow-up if patient alive at time of data cut-off).

The secondary outcome measures will include:

  • Need of cardiac surgery and time to cardiac surgery (defined as date of diagnosis of severe carcinoid heart disease to date of cardiac surgery).
  • Cardiovascular Death. Defined as death due to carcinoid heart disease or related heart failure according to the local site investigator.
Lung NET - Level 3 project

Real world retrospective study of therapies in lung and thymic carcinoids - A study of the ENETS Lung Task Force

Level: 3

Launch date: 1. quarter of 2023

Principle investigators: Thomas WALTER & Anna KOUMARIANOU

Project description:

This study is organized by the ENETs Lung Task Force and aims to retrospectively collect real-world data on the clinical efficacy and the antineoplastic effect of SSA and PRRT in typical and atypical neuroendocrine NETs.

All data will be collected from ENETs multidisciplinary centers and centers specialized in the field, to guarantee quality data.

The primary endpoint of this study is to assess the PFS of patients with advanced lung and thymic carcinoids treated with SSA and PRRT.

The secondary objectives of this study are to assess the doses and duration of treatment, the clinical efficacy (symptomatic response), the toxicity of SSA and PRRT, DCR, PFS at 12 months and the OS.

Other treatment parameters will be analyzed such as presence of a functioning syndrome, sequence of treatments, effectiveness of rechallenge with the same treatment, occurrence and reasons of dose modifications. A cost-effectiveness analysis of these treatments will be included.

The dataset has also the function to record current clinical practices around collaborative ENETs groups, and to disseminate the results in the form of abstracts and publications.