RegisterNET - A Registry for Neuroendocrine Tumors in the USA and Worldwide (RegisterNET)

November 11, 2025 updated by: Wren Laboratories LLC

A Registry for Neuroendocrine Tumors

Neuroendocrine tumors are derived from the neuroendocrine system of the gastroenteropancreatic and bronchopulmonary tract systems. Treatment options include surgery, medical and ablative therapies as well as peptide-receptor radionuclide therapy. Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive blood tests that can detect neuroendocrine tumor activity. A second challenge is to evaluate the effectiveness of molecular biomarkers in the natural history of this disease. RegisterNET registry aims at collecting data and blood samples from patients presenting with a NET. Data will be entered prospectively and anonymized after informed consent. All physicians who treat neuroendocrine tumor patients are invited to participate to the registry through prospective agreements and sub-study protocols with Wren Laboratories. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types and grades of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Background: Survival for neuroendocrine tumors is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. Non-invasive biomarkers have been identified that can improve diagnosis and prognosis of patients. Little, however, is known about the utility of these markers in clinical practice.

Objective: To systematically and prospectively collect clinical information and blood samples for NETest from neuroendocrine tumors to evaluate the clinical validity of this biomarker for diagnosis, surveillance, and prediction of disease prognosis and response to targeted therapeutics.

Methods: All neuroendocrine tumors (gastroenteropancreatic and pulmonary) are following informed consent. Data will be entered prospectively and anonymized. Patient history including a quality of life survey are completed by contributing physicians and blood sample is collected for analysis. All information will be transferred to the database. Evaluation of treatment modalities and patient outcomes (e.g. disease recurrence) will be assessed at follow-up times.

The primary objectives of the project are to:

  • monitor patients with neuroendocrine tumors
  • provide descriptive statistical analyses
  • assessment of diagnostic accuracy of NETest

The secondary objectives of the project include:

  • assessment of disease recurrence, progression and prognosis
  • analysis of patient survival

Analyses will include:

  1. Descriptive statistical analyses including demographics, site, treatment, QoL assessment.
  2. Clinical follow-up and blood chemistry results.
  3. Correlation analyses between blood results e.g., changes in NETest and clinical data. This will include assessment of the time at which the blood chemistry results significantly (and consistently) increases and the time of tumor recurrence and an evaluation whether the change in blood results is predictive of disease recurrence or progression. Changes can also be used for prognosis and evaluating response to therapies e.g., PRRT.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Branford, Connecticut, United States, 06405
        • Wren Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with a histologically confirmed diagnosis of a neuroendocrine tumor undergoing treatment and follow-up evaluation. This includes real-world patients as well as patients included in investigator-initiated clinical studies (IICS) e.g., PRRT or curative surgery.

Description

Inclusion Criteria:

  • Gastroenteropancreatic neuroendocrine tumor
  • Bronchopulmonary neuroendocrine tumor
  • Gastroenteropancreatic neuroendocrine carcinoma
  • Pre- and post-surgical patients
  • Watch & Wait/no treatment
  • Treatment including somatostatin analogues, PRRT, targeted therapies.
  • Patient provides informed consent

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor-related diagnosis
Time Frame: 1 year
Histological confirmation of neuroendocrine tumor
1 year
Tumor-related mortality
Time Frame: 10 years
Survival from disease
10 years
Tumor-related recurrence or progression
Time Frame: 5 years
Image-based identification of recurrent or progressive tumor disease
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Evaluation
Time Frame: 5 years
Questionnaire to evaluate quality of life status
5 years
Biomarker prediction of treatment response and disease relapse
Time Frame: 10 years
Biomarker prediction of treatment response and disease relapse. This involves measurements of changes in NETest levels between two time-points. Changes can be in actual values or be evaluated as % change. Alterations in blood measurements can be correlated with survival curves (PFS and/or OS).
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wren Laboratories LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimated)

October 21, 2014

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

November 11, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WREN_REGISTER_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identififed, anonymized information including changes in NETest and outcomes e.g., PFS.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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