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Neuroendocrine TumorRegisterNETNCT02270567

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

An observational study of Neuroendocrine Tumor and Carcinoid, run by Wren Laboratories LLC at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
NETest
Type of treatment
Medical device
How many people
400 participants
Where
1 siteUnited States
Study dates
Feb 2015to Dec 2030
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Wren Laboratories

    Branford, Connecticut, 06405

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
NETest
Keywords
PRRT, Somatostatin Analogue, NETest, Progression, PPQ
Medical subject headings
Neuroendocrine Tumors, Carcinoid Tumor, Carcinoma, Neuroendocrine, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NETestDevice

    Also called Multianalyte Algorithm Analysis of circulating neuroendocrine tumor transcripts

    Non-invasive blood test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor-related recurrence or progression

    Image-based identification of recurrent or progressive tumor disease

    Measured: 5 years

  2. Tumor-related diagnosis

    Histological confirmation of neuroendocrine tumor

    Measured: 1 year

  3. Tumor-related mortality

    Survival from disease

    Measured: 10 years

Secondary outcomes (2)

  1. Quality of Life Evaluation

    Questionnaire to evaluate quality of life status

    Measured: 5 years

  2. Biomarker prediction of treatment response and disease relapse

    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).

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionMar 2018
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02270567
Sponsor's protocol ID
WREN_REGISTER_01
Acronym
RegisterNET
Status last verified
Nov 2025
First submitted
29 Sep 2014
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: De-identififed, anonymized information including changes in NETest and outcomes e.g., PFS.

Publications

  • Modlin IM, Drozdov I, Kidd M. The identification of gut neuroendocrine tumor disease by multiple synchronous transcript analysis in blood. PLoS One. 2013 May 15;8(5):e63364. doi: 10.1371/journal.pone.0063364. Print 2013.

    PubMed 23691035

  • Modlin IM, Drozdov I, Kidd M. Gut neuroendocrine tumor blood qPCR fingerprint assay: characteristics and reproducibility. Clin Chem Lab Med. 2014 Mar;52(3):419-29. doi: 10.1515/cclm-2013-0496.

    PubMed 24127543

  • Modlin IM, Drozdov I, Alaimo D, Callahan S, Teixiera N, Bodei L, Kidd M. A multianalyte PCR blood test outperforms single analyte ELISAs (chromogranin A, pancreastatin, neurokinin A) for neuroendocrine tumor detection. Endocr Relat Cancer. 2014 Aug;21(4):615-28. doi: 10.1530/ERC-14-0190.

    PubMed 25015994

  • Modlin IM, Drozdov I, Bodei L, Kidd M. Blood transcript analysis and metastatic recurrent small bowel carcinoid management. BMC Cancer. 2014 Aug 5;14:564. doi: 10.1186/1471-2407-14-564.

    PubMed 25095873

  • Kidd M, Drozdov IA, Chirindel A, Nicolas G, Imagawa D, Gulati A, Tsuchikawa T, Prasad V, Halim AB, Strosberg J. NETest(R) 2.0-A decade of innovation in neuroendocrine tumor diagnostics. J Neuroendocrinol. 2025 Apr;37(4):e70002. doi: 10.1111/jne.70002. Epub 2025 Feb 13.

    PubMed 39945192

  • Liu E, Paulson S, Gulati A, Freudman J, Grosh W, Kafer S, Wickremesinghe PC, Salem RR, Bodei L. Assessment of NETest Clinical Utility in a U.S. Registry-Based Study. Oncologist. 2019 Jun;24(6):783-790. doi: 10.1634/theoncologist.2017-0623. Epub 2018 Aug 29.

    PubMed 30158287

  • Kidd M, Kitz A, Drozdov I, Modlin I. Neuroendocrine Tumor Omic Gene Cluster Analysis Amplifies the Prognostic Accuracy of the NETest. Neuroendocrinology. 2021;111(5):490-504. doi: 10.1159/000508573. Epub 2020 May 11.

    PubMed 32392558

Questions about this trial

What is this clinical trial studying?

An observational study of Neuroendocrine Tumor and Carcinoid, run by Wren Laboratories LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor-related recurrence or progression (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02270567, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.

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