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

NCT ID: NCT01216267

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-31

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

Conditions

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Neuroendocrine Carcinoma (Carcinoid)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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lansoprazole

lansoprazole for 7 days

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

lansoprazole 30 mg HS x 7 days

lansoprazole

Intervention Type DRUG

lanzoprazole 30 mg HS for 7 days

Interventions

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Lansoprazole

lansoprazole 30 mg HS x 7 days

Intervention Type DRUG

lansoprazole

lanzoprazole 30 mg HS for 7 days

Intervention Type DRUG

Other Intervention Names

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Prevacid pravacid

Eligibility Criteria

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Inclusion Criteria

* having neuro-endocrine disease


* healthy

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:


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role lead

Responsible Party

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Stanislaus H. van Uum

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stan Van Uum, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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London Health Sciences Center and St. Joseph's Health Care

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HSREB16279

Identifier Type: -

Identifier Source: org_study_id

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