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

This study is currently recruiting participants.
Verified November 2016 by Wren Laboratories LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02270567
First Posted: October 21, 2014
Last Update Posted: November 2, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Wren Laboratories LLC
  Purpose
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 Intervention
Neuroendocrine Tumor Carcinoid Neuroendocrine Carcinoma Device: NETest

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Registry for Neuroendocrine Tumors in the USA

Resource links provided by NLM:


Further study details as provided by Wren Laboratories LLC:

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

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

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


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

  • 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

Estimated Enrollment: 500
Study Start Date: February 2015
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NETest
    Non-invasive blood test
    Other Name: Multianalyte Algorithm Analysis of circulating neuroendocrine tumor transcripts
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02270567


Locations
United States, Connecticut
Wren Laboratories Recruiting
Branford, Connecticut, United States, 06405
Contact: Nancy Smith-Teixeira, MS (Nursing)    855-295-8410 ext 301    nancy@wrenlaboratories.com   
Contact: Mark Kidd, PhD    203-208-3464    mark@wrenlaboratories.com   
Principal Investigator: Mark Kidd, PhD         
Sponsors and Collaborators
Wren Laboratories LLC
  More Information

Additional Information:
Publications:
Responsible Party: Wren Laboratories LLC
ClinicalTrials.gov Identifier: NCT02270567     History of Changes
Other Study ID Numbers: WREN_REGISTER_01
First Submitted: September 29, 2014
First Posted: October 21, 2014
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Carcinoma, Neuroendocrine
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial