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.
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
- Conditions the study is for
- Neuroendocrine Tumor, Carcinoid, Neuroendocrine Carcinoma
- 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
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.
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:
- 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.
- Conditions
- Neuroendocrine Tumor, Carcinoid, Neuroendocrine Carcinoma
- 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.
Tumor-related recurrence or progression
Image-based identification of recurrent or progressive tumor disease
Measured: 5 years
Tumor-related diagnosis
Histological confirmation of neuroendocrine tumor
Measured: 1 year
Tumor-related mortality
Survival from disease
Measured: 10 years
Secondary outcomes (2)
Quality of Life Evaluation
Questionnaire to evaluate quality of life status
Measured: 5 years
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.
- First posted21 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2018
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Wren Laboratories LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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 23691035Modlin 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 24127543Modlin 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 25015994Modlin 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 25095873Kidd 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 39945192Liu 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 30158287Kidd 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