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

NCT02270567 | Enrolling By Invitation DMC

• 1 other identifier: WREN_REGISTER_01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Neuroendocrine Tumor; Carcinoid; Neuroendocrine Carcinoma

Keywords

PRRT; Somatostatin Analogue; NETest; Progression; PPQ

Outcome Measures

Primary Outcomes (3)

• Tumor-related recurrence or progression

  Image-based identification of recurrent or progressive tumor disease

  5 years

• Tumor-related diagnosis

  Histological confirmation of neuroendocrine tumor

  1 year

• Tumor-related mortality

  Survival from disease

  10 years

Secondary Outcomes (2)

• Quality of Life Evaluation

  5 years

• Biomarker prediction of treatment response and disease relapse

  10 years

Interventions

NETest DEVICE

Non-invasive blood test

Also known as: Multianalyte Algorithm Analysis of circulating neuroendocrine tumor transcripts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Wren Laboratories LLC: lead

Study Sites (1)

Wren Laboratories

Branford, Connecticut, 06405, United States

Location

Related Publications (7)

• 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.

  PMID: 23691035 BACKGROUND

• 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.

  PMID: 24127543 BACKGROUND

• 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.

  PMID: 25015994 BACKGROUND

• 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.

  PMID: 25095873 BACKGROUND

• 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.

  PMID: 39945192 RESULT

• 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.

  PMID: 30158287 RESULT

• 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.

  PMID: 32392558 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection (RNA stabilization tube) used for neuroendocrine tumor biomarker measurements (NETest)

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Carcinoma, Neuroendocrine; Disease Progression

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 21, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2018
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)