The aim of this study is to investigate if the NETest is useful in the follow up program after curative resection in patients with pNET. Therefore the diagnostic accuracy of the NETest in resected patients with pNET will be analysed. The study is…
ID
Source
Brief title
Condition
- Neoplastic and ectopic endocrinopathies
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the outcome of the NETest of the patients in the three
different groups. A NET score (0-100%) is obtained from algorithmic analyses of
PCR data using MATLAB (R2011a, Mathworks, Natick, MA, USA) . A value >= 20% will
be considered as a positive test. Scores randing from 0-20% = negative (no
evidence of tumor disease activity: NET-negative).
Scores ranging from 20-43% are considered *low activity* (NET-positive).
Scores ranging from 44-100% are considered *high activity* (NET-positive).
Secondary outcome
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Background summary
Pancreatic neuroendocrine tumors (pNET) a rare but in the recent years, the
incidence is raising. Based on the overproduction of hormones, clinical
syndromes may occur and pNET can be divided in functioning and non-functioning
pNET. Although most pNET are non-functioning tumor, these tumors may produce
hormones as well. These hormones can be measured in the blood and therefore
they can be used as tumor markers. The best known tumor marker is chromogranin
A (CgA). The sensitivity of CgA varied from 24-88%. In patients with an high
tumor load, the diagnostic accuracy of CgA becomes better. In the cohort of
resected non-functioning pNET (NF-pNET) of the Academic Medical Center (AMC),
Amsterdam, the sensitivity and specificity for the detection of metastases
after curative resection for CgA is respectively 67% and 68%. The diagnostic
accuracy of CgA is moderate, since CgA is false positive in other conditions as
well. A elevated value of CgA without evidence of recurrent disease on
radiological imaging, may cause a lot anxiety in the patients.
In case of recurrent disease, multiple treatment options are available such as
local resection or radiofrequency ablation (RFA) 9 of the metastases,
chemotherapy, somatostatin analogues, peptide receptor radionuclide therapy and
new agents such as Everolimus and Sunitinib. Early detection of recurrent
disease and therefore early start of further treatment are the main goal during
follow up after curative resection for pNET.
A complete and uniform follow up program is not yet available. The current
program include CgA determination and radiological examinations. Radiological
examination often consist of an CT/MRI on a yearly basis. However, octreotide
scintigraphy or 68Galium PET are also available. Since CgA has a moderate
accuracy and radiological imaging are less sensitive in small lesions, the
ideal follow up program is still on debate.
Modlin et al developed a new diagnostic test, the NETest. This is a
multianalyte PCR blood test, specific for neuroendocrine tumors. With a
sensitivity and specificity of both 92.8% for diagnosis, the NETest seems
promising. The NETest may be used during follow up in the early detection of
recurrent disease after curative resection for pNET. Furthermore, in patients
with (microscopically) positive resection margins, possible present residual
tumor can be demonstrated. An early treatment or adjuvant treatment can be
started in these patients.
Study objective
The aim of this study is to investigate if the NETest is useful in the follow
up program after curative resection in patients with pNET. Therefore the
diagnostic accuracy of the NETest in resected patients with pNET will be
analysed.
The study is based on the following hypothesis:
H0: the NETest has a better diagnostic accuracy for the detection of recurrent
disease or tumor residual after a curative resection for pNET in comparison
with the current follow up program.
The study is intended to analyse three groups and we will test the following
assumptions:
1. Patients with pNET have a negative NETest after their curative R0 resection
2. Patients with pNET have a positive NETest if they developed recurrent
disease or metastases after their R0 resection.
3. Patients with pNET have a positive NETest after their R1/R2 resection
A R0 resection is defined as negative resection margins. R1 resection is
defined as the presence of tumor cells within 1 mm of the resection margin.
R2 resection is defined as macroscopic positive resection margins.
Study design
The study is an prospective cohort study.
Study burden and risks
The blood samples will be obtained during the standard laboratory tests in the
outpatients clinic. There may be risk of infection of the puncture site or an
hematoma. The burden of the laboratory test will not be higher by the extra
blood samples.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- the patient is 18 years of older
- the patient is primarily treated with a surgical resection for pNET
- the patients is in the follow up program of the Academic Medical Center of Amsterdam (AMC)
- the patients is able to understand the given information
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- the patient is younger than 18 years
- the patient is not in the follow up program of the AMC
- the patient had metastatic disease at the time of the primary tumor
- the patient is not able to give informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50925.018.15 |