RegisterNET - A Registry for Neuroendocrine Tumors in the USA (RegisterNET)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02270567|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2014
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment|
|Neuroendocrine Tumor Carcinoid Neuroendocrine Carcinoma||Device: NETest|
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:
- Descriptive statistical analyses including demographics, site, treatment, QoL assessment.
- Clinical follow-up and blood chemistry results.
- 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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||100 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||A Registry for Neuroendocrine Tumors in the USA|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2020|
- Device: NETest
Non-invasive blood testOther Name: Multianalyte Algorithm Analysis of circulating neuroendocrine tumor transcripts
- 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
- 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
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
|United States, Connecticut|
|Branford, Connecticut, United States, 06405|