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

NCT02759718 | Unknown Phase 4 DMC

• 1 other identifier: CgA_PNET_AMC_Korea
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non Functioning Pancreatic Endocrine Tumor

Keywords

pancreatic neuroendocrine tumor; chromogranin A

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of th CgA in the patient with PNET, change from preoperative levels of CgA at 3 months

  In the PNET group, the plasma level of CgA was regularly measured.

  preoperation, 3 months

Secondary Outcomes (2)

• Diagnostic accuracy of th CgA in the patient with disease progression, change from preoperative levels of CgA at 3, 6,12, and 24 months

  preoperation, 3 months, 6 months, 12months, 24 months

• Disease progression of PNET using CT imaging, change from preoperative imaging of CT at 3, 6,12, and 24 months

  preoperation, 3 months, 6 months, 12months, 24 months

Study Arms (1)

pancreatic neuroendocrine tumor

EXPERIMENTAL

chromogranin A

Biological: Chromogranin A

Interventions

Chromogranin A BIOLOGICAL

The plasma level of chromogranin A (CgA) was measured in enrolled patients who was diagnosed as PNET in preoperative condition.After surgical resection, the CgA level was only measured in the the patient with PNET. In the PNET group, the CgA level was regularly checked in a 3, 6, 12, and 24 months after surgical resection.

Also known as: CgA

pancreatic neuroendocrine tumor

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having differential diagnosis with PNET in preoperative radiologic diagnosis
• Life expectancy is equal or more than 6 months
• whom written informed consent to participate in the study

You may not qualify if:

• renal insufficiency
• taking proton pump inhibitor
• cardiac insufficiency grade 3 and 4
• chronic atrophic gastritis.
• multiple endocrine neoplasia or Cushing's syndrome or mixed tumours or pheochromocytoma or medullary thyroid carcinoma.
• previous history of malignant tumour, with the exception of carcinoma in situ of the uterine cervix or non-melanoma skin cancer
• whom cannot be followed up during the study because of psychology or geographic reasons.

Sponsors & Collaborators

• Asan Medical Center: lead
• Novartis: collaborator

MeSH Terms

Conditions

Non functioning pancreatic endocrine tumor; Adenoma, Islet Cell

Interventions

Chromogranin A

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chromogranins; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Songcheol Kim, MD PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 3, 2016
• Study Start: June 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 3, 2016

Record last verified: 2016-04