Non Functioning Pancreatic Endocrine Tumor Clinical Trial
Official title:
Clinical Effectiveness of Serum Chromogranin A (CgA) Levels on Diagnostic Relevance, Response After Surgical Resection and Recurrence of Pancreatic Endocrine Tumors (PET)
Chromogranin A (CgA) is a glycoprotein with a molecular weight of 49 to 52 kDa produced by
chromaffin cells of the adrenal medulla, enterochromaffin-like (ECL) cells, and endocrine
cells of the stomach and pancreas, and it is the precursor to several functional peptides
including vasostatin and pancreastatin.
Importantly, CgA can be measured in the serum or plasma or detected within the secretory
vesicles as a general diagnostic biomarker for neuroendocrine tumors (NETs), and plasma CgA
levels also provide information regarding tumor burden and response to treatment. It has a
sensitivity and specificity between 27% and 81%.
Some studies have noted an association between CgA concentrations and tumor location or
degree of differentiation. It has also been proposed that plasma CgA levels are more
frequently elevated in well-differentiated tumors compared with poorly differentiated tumors
of the midgut. Some other clinical series have provided evidence of an association between
plasma CgA levels and the extent of disease, tumor burden, or presence of metastases, and
high baseline levels of CgA are suggestive of a poor prognosis.
However, there exist still controversies the effectiveness of serum CgA levels on diagnostic
relevance, treatment response after surgical resection or sandostatin analog,
clinicopathologic features of pancreatic neuroendocrine tumors (PNETs).
To date, moreover, a precise association between CgA levels and survival has not been
clearly demonstrated, although a number of studies suggest that this relationship may exist.
There, especially, is no relevant data on value of serum CgA level for clinical usefulness
in Korean population.
An interventional, prospective, multi center pilot study to assess the clinical relevance of
CgA levels in patients with PNET as performed in current clinical practice.
There will be a measurement of CgA levels at baseline (preoperative measures after consent)
and afterwards, in 3, 6, 12, and 24 months after resection. Immunoradiometric assay (IRMA,
normal values: < 100 ng/mL) will be used.
The collection of blood samples will proceed as detailed below:
Extraction of samples for serum collection:
7 ml of blood without anticoagulants will be allowed to sit for 30 min at room temperature
before the serum is separated by centrifugation (3500 rpm). The serum will be stored at
-20ºC
Assessments: Baseline (preoperative measures after consent), 3,6, 12, and 24 months
Clinical parameters: weight, height, performance status, vital signs including blood
pressure, clinical signs and symptoms, survival data
Blood biochemical parameters: Sodium, potassium, calcium, glucose, urea, creatinina,
bilirubin, alkaline phosphatase, aspartate transaminase (AST), and alanine transaminase
(ALT).
Computed tomography (CT) : preoperative condition, and 3,6,12,24 months after resection.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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