Non Functioning Pancreatic Endocrine TumorPhase 4CgANCT02759718
Clinical Effectiveness of Serum Chromogranin A Levels on Diagnostic of Pancreatic Neuroendocrine Tumors
A Phase 4 study testing Chromogranin A in people with Non Functioning Pancreatic Endocrine Tumor, run by Asan Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Non Functioning Pancreatic Endocrine Tumor
- What is being tested?
- Chromogranin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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%.
Read more
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.
Read the 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.
- Being tested
- Chromogranin A
- Keywords
- pancreatic neuroendocrine tumor, chromogranin A
- Medical subject headings
- Non functioning pancreatic endocrine tumor, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromogranin ABiological
Also called CgA
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.
| Study group | Role | What they receive |
|---|---|---|
| pancreatic neuroendocrine tumor | Experimental | chromogranin A Receives: Biological: Chromogranin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
In the PNET group, the plasma level of CgA was regularly checked to follow up the status of disease progression.
Measured: 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
In the PNET group, the CT was regularly checked to follow up the status of disease progression.
Measured: preoperation, 3 months, 6 months, 12months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startJun 2012
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Functioning Pancreatic Endocrine TumorStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Song Cheol Kim, Asan Medical Center
- Investigators
- Songcheol Kim, MD PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759718
- Sponsor's protocol ID
- CgA_PNET_AMC_Korea
- Acronym
- CgA
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Serum Chromogranin A (CgA) Levels on Diagnostic Relevance, Response After Surgical Resection and Recurrence of Pancreatic Endocrine Tumors (PET)
- ClinicalTrials.gov ID
- NCT02759718
- Acronym / sponsor ID
- CgA / CgA_PNET_AMC_Korea
- Keywords
- pancreatic neuroendocrine tumor, chromogranin A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jun 2012
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic neuroendocrine tumor | Experimental | Biological: Chromogranin Achromogranin A |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromogranin AAlso: CgAThe 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. | Biological | pancreatic neuroendocrine tumor |
Primary outcome
Diagnostic accuracy of th CgA in the patient with PNET, change from preoperative levels of CgA at 3 months
Time frame: preoperation, 3 months
In the PNET group, the plasma level of CgA was regularly measured.
2 secondary outcomes
Diagnostic accuracy of th CgA in the patient with disease progression, change from preoperative levels of CgA at 3, 6,12, and 24 months
Time frame: 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
Time frame: preoperation, 3 months, 6 months, 12months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Non Functioning Pancreatic Endocrine Tumor
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
Active, not recruitingPhase 1/2
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
Non Small Cell Lung Cancer, Advanced Solid Tumor
RecruitingObservational study
Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss After Pancreatectomy in Non-Diabetic Patients
Pancreatectomy, Diabetes Mellitus Type 2
RecruitingObservational study
Understanding New Cachexia Subtypes Through Observational Epidemiological Research
Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma
RecruitingPhase 2
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
Breast Cancer, Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Songcheol Kim, MD PhD principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chromogranin A in people with Non Functioning Pancreatic Endocrine Tumor, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of th CgA in the patient with PNET, change from preoperative levels of CgA at 3 months (time frame: preoperation, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.