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Enrolling by Invitation

NCT Number: NCT02270567

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

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.

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Key information

Conditions

Neuroendocrine Tumor Adenocarcinoma Carcinoid Carcinoid Tumor Carcinoma Carcinoma, Neuroendocrine Disease Attributes Disease Progression Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Carcinoma Neuroendocrine Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wren Laboratories

Branford, Connecticut, 06405, United States

About this study

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:

  • Descriptive statistical analyses including demographics, site, treatment, QoL assessment.
  • Clinical follow-up and blood chemistry results.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NETest

Device

Non-invasive blood test

Other names: Multianalyte Algorithm Analysis of circulating neuroendocrine tumor transcripts

Primary outcomes

  1. Tumor-related recurrence or progression

    Time frame: 5 years

    Image-based identification of recurrent or progressive tumor disease

  2. Tumor-related diagnosis

    Time frame: 1 year

    Histological confirmation of neuroendocrine tumor

  3. Tumor-related mortality

    Time frame: 10 years

    Survival from disease

Secondary outcomes

  1. Quality of Life Evaluation

    Time frame: 5 years

    Questionnaire to evaluate quality of life status

  2. 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).

Sponsors and collaborators

Lead sponsor

Wren Laboratories LLC

Industry

Registry information

Official study title

A Registry for Neuroendocrine Tumors

Acronym: RegisterNET

Important dates

Study start
2015
Primary completion
2018
Study completion
2030
First posted
Oct 21, 2014
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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