Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples

Study Overview
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Brief Summary
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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.

Detailed Description
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Patient group: patients with neuroendocrine tumors (active or inactive) Healthy volunteers

Official Title
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Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples

Conditions
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Neuroendocrine Carcinoma (Carcinoid)

Intervention / Treatment
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* Drug: Lansoprazole
* Drug: lansoprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lansoprazole<br>lansoprazole for 7 days | Drug: Lansoprazole<br>* lansoprazole 30 mg HS x 7 days<br>* Other names: Prevacid;Drug: lansoprazole<br>* lanzoprazole 30 mg HS for 7 days<br>* Other names: pravacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chromogranin A, neuroendocrine, carcinoid, Proton Pump Inhibitor