Clinical Effectiveness of Serum Chromogranin A Levels on Diagnostic of Pancreatic Neuroendocrine Tumors (CgA)
Primary Purpose
Non Functioning Pancreatic Endocrine Tumor
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Chromogranin A
Sponsored by
About this trial
This is an interventional diagnostic trial for Non Functioning Pancreatic Endocrine Tumor focused on measuring pancreatic neuroendocrine tumor, chromogranin A
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pancreatic neuroendocrine tumor
Arm Description
chromogranin A
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Diagnostic accuracy of th CgA in the patient with disease progression, change from preoperative levels of CgA at 3, 6,12, and 24 months
In the PNET group, the plasma level of CgA was regularly checked to follow up the status of disease progression.
Disease progression of PNET using CT imaging, change from preoperative imaging of CT at 3, 6,12, and 24 months
In the PNET group, the CT was regularly checked to follow up the status of disease progression.
Full Information
NCT ID
NCT02759718
First Posted
April 26, 2016
Last Updated
April 29, 2016
Sponsor
Asan Medical Center
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT02759718
Brief Title
Clinical Effectiveness of Serum Chromogranin A Levels on Diagnostic of Pancreatic Neuroendocrine Tumors
Acronym
CgA
Official Title
Clinical Effectiveness of Serum Chromogranin A (CgA) Levels on Diagnostic Relevance, Response After Surgical Resection and Recurrence of Pancreatic Endocrine Tumors (PET)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Functioning Pancreatic Endocrine Tumor
Keywords
pancreatic neuroendocrine tumor, chromogranin A
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pancreatic neuroendocrine tumor
Arm Type
Experimental
Arm Description
chromogranin A
Intervention Type
Biological
Intervention Name(s)
Chromogranin A
Other Intervention Name(s)
CgA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of th CgA in the patient with PNET, change from preoperative levels of CgA at 3 months
Description
In the PNET group, the plasma level of CgA was regularly measured.
Time Frame
preoperation, 3 months
Secondary Outcome Measure Information:
Title
Diagnostic accuracy of th CgA in the patient with disease progression, change from preoperative levels of CgA at 3, 6,12, and 24 months
Description
In the PNET group, the plasma level of CgA was regularly checked to follow up the status of disease progression.
Time Frame
preoperation, 3 months, 6 months, 12months, 24 months
Title
Disease progression of PNET using CT imaging, change from preoperative imaging of CT at 3, 6,12, and 24 months
Description
In the PNET group, the CT was regularly checked to follow up the status of disease progression.
Time Frame
preoperation, 3 months, 6 months, 12months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songcheol Kim, MD PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Effectiveness of Serum Chromogranin A Levels on Diagnostic of Pancreatic Neuroendocrine Tumors
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