RegisterNET - A Registry for Neuroendocrine Tumors in the USA

Neuroendocrine Carcinoma Clinical Trial

— RegisterNET  

Official title:

A Registry for Neuroendocrine Tumors in the USA

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02270567
• Other study ID #: WREN_REGISTER_01
• Status: Enrolling by invitation
• Start date: February 2015
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Wren Laboratories LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 2025
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Gastroenteropancreatic neuroendocrine tumor

• Bronchopulmonary neuroendocrine tumor

• Gastroenteropancreatic neuroendocrine carcinoma

• Patient provides informed consent

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Carcinoid
• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma
• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Device:
• NETest
Non-invasive blood test

Locations

Country	Name	City	State
United States	Wren Laboratories	Branford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Wren Laboratories LLC

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 2 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor-related recurrence	Image-based identification of recurrent tumor disease	5 years
Primary	Tumor-related diagnosis	Histological confirmation of neuroendocrine tumor	1 year
Primary	Tumor-related mortality	Survival from disease	10 years
Secondary	Quality of Life Evaluation	Questionnaire to evaluate quality of life status	5 years
Secondary	Biomarker prediction of treatment response and disease relapse	Biomarker prediction of treatment response and disease relapse	10 years