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Clinical Effectiveness of Serum Chromogranin A Levels on Diagnostic of Pancreatic Neuroendocrine Tumors

2016-05-03 21:38:21 | BioPortfolio

Summary

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.

Description

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Non Functioning Pancreatic Endocrine Tumor

Intervention

Chromogranin A

Status

Active, not recruiting

Source

Asan Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-05-03T21:38:21-0400

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Medical and Biotech [MESH] Definitions

A form of multiple endocrine neoplasia that is characterized by the combined occurrence of tumors in the PARATHYROID GLANDS, the PITUITARY GLAND, and the PANCREATIC ISLETS. The resulting clinical signs include HYPERPARATHYROIDISM; HYPERCALCEMIA; HYPERPROLACTINEMIA; CUSHING DISEASE; GASTRINOMA; and ZOLLINGER-ELLISON SYNDROME. This disease is due to loss-of-function of the MEN1 gene, a tumor suppressor gene (GENES, TUMOR SUPPRESSOR) on CHROMOSOME 11 (Locus: 11q13).

A 36-amino acid pancreatic hormone that is secreted mainly by endocrine cells found at the periphery of the ISLETS OF LANGERHANS and adjacent to cells containing SOMATOSTATIN and GLUCAGON. Pancreatic polypeptide (PP), when administered peripherally, can suppress gastric secretion, gastric emptying, pancreatic enzyme secretion, and appetite. A lack of pancreatic polypeptide (PP) has been associated with OBESITY in rats and mice.

A type of chromogranin which was initially characterized in a rat PHEOCHROMOCYTOMA CELL LINE. It is found in many species including human, rat, mouse, and others. It is an acidic protein with 626 to 657 amino acid residues. In some species, it inhibits secretion of PARATHYROID HORMONE or INSULIN and exerts bacteriolytic effects in others.

A type of chromogranin which was first isolated from CHROMAFFIN CELLS of the ADRENAL MEDULLA but is also found in other tissues and in many species including human, bovine, rat, mouse, and others. It is an acidic protein with 431 to 445 amino acid residues. It contains fragments that inhibit vasoconstriction or release of hormones and neurotransmitter, while other fragments exert antimicrobial actions.

A nodular organ in the ABDOMEN that contains a mixture of ENDOCRINE GLANDS and EXOCRINE GLANDS. The small endocrine portion consists of the ISLETS OF LANGERHANS secreting a number of hormones into the blood stream. The large exocrine portion (EXOCRINE PANCREAS) is a compound acinar gland that secretes several digestive enzymes into the pancreatic ductal system that empties into the DUODENUM.

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