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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02270567
Recruitment Status : Active, not recruiting
First Posted : October 21, 2014
Last Update Posted : November 21, 2018
Information provided by (Responsible Party):
Wren Laboratories LLC

Brief Summary:
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 in the USA. Data will be entered prospectively and anonymized after informed consent. All physicians who treat neuroendocrine tumor patients are invited to participate to the registry. 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.

Condition or disease Intervention/treatment
Neuroendocrine Tumor Carcinoid Neuroendocrine Carcinoma Device: NETest

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 from neuroendocrine tumors in the USA based a histologically confirmed diagnosis.

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 molecular-based blood tests

The secondary objectives of the project include:

  • assessment of disease recurrence
  • 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 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Registry for Neuroendocrine Tumors in the USA
Study Start Date : February 2015
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: NETest
    Non-invasive blood test
    Other Name: Multianalyte Algorithm Analysis of circulating neuroendocrine tumor transcripts

Primary Outcome Measures :
  1. Tumor-related recurrence [ Time Frame: 3 years ]
    Image-based identification of recurrent tumor disease

  2. Tumor-related diagnosis [ Time Frame: 1 year ]
    Histological confirmation of neuroendocrine tumor

  3. Tumor-related mortality [ Time Frame: 5 years ]
    Survival from disease

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 5 years ]
    Quality of life

  2. Biomarker prediction of treatment response and disease relapse [ Time Frame: 5 years ]
    Biomarker prediction of treatment response and disease relapse

Biospecimen Retention:   Samples With DNA
Blood collection (EDTA tube) used for neuroendocrine tumor biomarker measurements

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with a histologically confirmed diagnosis of a neuroendocrine tumour

Inclusion Criteria:

  • Gastroenteropancreatic neuroendocrine tumor
  • Bronchopulmonary neuroendocrine tumor
  • Gastroenteropancreatic neuroendocrine carcinoma
  • Patient provides informed consent

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02270567

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United States, Connecticut
Wren Laboratories
Branford, Connecticut, United States, 06405
Sponsors and Collaborators
Wren Laboratories LLC

Additional Information:
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Responsible Party: Wren Laboratories LLC Identifier: NCT02270567     History of Changes
Other Study ID Numbers: WREN_REGISTER_01
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial