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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
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 26, 2016
    Last Updated
    April 29, 2016
    Sponsor
    Asan Medical Center
    Collaborators
    Novartis
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    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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