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

January 14, 2013 updated by: Stanislaus H. van Uum, University of Western Ontario, Canada

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • London Health Sciences Center and St. Joseph's Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lansoprazole
lansoprazole for 7 days
Drug: Lansoprazole
lansoprazole 30 mg HS x 7 days
Other Names:
  • Prevacid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chromogranin A concentration serum
Time Frame: 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.
single time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of PPI on chromogranin A concentration
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Stan Van Uum, MD PhD, Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSREB16279

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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