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

Not Applicable

Completed

• Conditions: Neuroendocrine Carcinoma (Carcinoid)
• Interventions: Drug: lansoprazole

• Registration Number: NCT01216267
• Lead Sponsor: University of Western Ontario, Canada

Brief Summary

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

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

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-07
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lansoprazole	lansoprazole	lansoprazole for 7 days

Primary Outcome Measures

Name	Time	Method
chromogranin A concentration serum	single time	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.

Secondary Outcome Measures

Name	Time	Method
Effect of PPI on chromogranin A concentration	2 weeks	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.

Trial Locations

Locations (1)

London Health Sciences Center and St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada