RegisterNET - A Registry for Neuroendocrine Tumors in the USA
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/23/2018 |
| Start Date: | February 2015 |
| End Date: | March 2020 |
A Registry for Neuroendocrine Tumors in the USA
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.
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.
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.
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.
Inclusion Criteria:
- Gastroenteropancreatic neuroendocrine tumor
- Bronchopulmonary neuroendocrine tumor
- Gastroenteropancreatic neuroendocrine carcinoma
- Patient provides informed consent
Exclusion Criteria:
We found this trial at
1
site
Branford, Connecticut 06405
Principal Investigator: Mark Kidd, PhD
Phone: 855-295-8410
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