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

Primary Purpose

Neuroendocrine Carcinoma (Carcinoid)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lansoprazole
lansoprazole
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Carcinoma (Carcinoid) focused on measuring chromogranin A, neuroendocrine, carcinoid, Proton Pump Inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

lansoprazole

Arm Description

lansoprazole for 7 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 5, 2010
Last Updated
January 14, 2013
Sponsor
University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01216267
Brief Title
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples
Official Title
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Carcinoma (Carcinoid)
Keywords
chromogranin A, neuroendocrine, carcinoid, Proton Pump Inhibitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lansoprazole
Arm Type
Active Comparator
Arm Description
lansoprazole for 7 days
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
Prevacid
Intervention Description
lansoprazole 30 mg HS x 7 days
Intervention Type
Drug
Intervention Name(s)
lansoprazole
Other Intervention Name(s)
pravacid
Intervention Description
lanzoprazole 30 mg HS for 7 days
Primary Outcome Measure Information:
Title
chromogranin A concentration serum
Description
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.
Time Frame
single time
Secondary Outcome Measure Information:
Title
Effect of PPI on chromogranin A concentration
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Van Uum, MD PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Center and St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

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

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