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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01216267

Enrollment

200

Registered

2010-10-07

Start date

2010-06-30

Completion date

2012-01-31

Last updated

2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Carcinoma (Carcinoid)

Keywords

chromogranin A, neuroendocrine, carcinoid, Proton Pump Inhibitor

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

Interventions

DRUGLansoprazole

lansoprazole 30 mg HS x 7 days

DRUGlansoprazole

lanzoprazole 30 mg HS for 7 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026