Neuroendocrine Carcinoma (Carcinoid) Clinical Trial
Official title:
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples
| Verified date | January 2013 |
| Source | University of Western Ontario, Canada |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
The goal of this study is to compare several methods for measurement of Chromogranin A in
their ability to serve as a marker for disease activity in patients with neuroendocrine
tumors.
Further, in a subgroup, we will determine if taking a proton pump inhibitor affects
Chromogranin A levels.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | January 2012 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Patients: Inclusion Criteria: - having neuro-endocrine disease Exclusion Criteria: - age below 18 or above 70 years - prostate cancer - kidney failure (estimated GF < 30 mL/Min) - heart failure - chronic atrophic gastritis - pregnancy Healthy subjects: Inclusion Criteria: - healthy Exclusion Criteria: - age below 18 or above 70 years - taking any chronic medication (except OCP) - prostate cancer - kidney failure (estimated GFR < 30 mL/min) - heart failure - pheochromocytoma - islet cell tumors - medullary thyroid cancer - essential hypertension - neurofibromatosis - use of proton pump inhibitors - chronic atrophic gastritis - pregnancy |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Canada | London Health Sciences Center and St. Joseph's Health Care | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University of Western Ontario, Canada |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | chromogranin A concentration serum | For determination of normal CgA range, we will recruit 60 healthy subjects (30 female, 30 male), in whom a single plasma sample will be obtained for measurement of CgA B For determination of CgA in patients with carcinoid disease (active or inactaive), we wil recruit 200 patients with carcinoid disease from our local neuroendocinre oncology clinic. | single time | No |
| Secondary | Effect of PPI on chromogranin A concentration | To determine the effect of PPI on chromogranin A concentration, we will recruit a subgroup of 12 healthy subjects who will take a bedtime lansoprazole 30 mg for 7 days. Fasting serum samples for CgA will be obtained at day 7 and 1, 2, 4, and 7 days after discontinuation of the PPI. | 2 weeks | No |