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

NCT01216267 | Completed

• 1 other identifier: HSREB16279
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Carcinoma (Carcinoid)

Keywords

chromogranin A; neuroendocrine; carcinoid; Proton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  single time

Secondary Outcomes (1)

• Effect of PPI on chromogranin A concentration

  2 weeks

Study Arms (1)

lansoprazole

ACTIVE COMPARATOR

lansoprazole for 7 days

Drug: Lansoprazole

Interventions

lansoprazole DRUG

lansoprazole 30 mg HS x 7 days

Also known as: Prevacid

lansoprazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having neuro-endocrine disease

You may not qualify if:

• age below 18 or above 70 years
• prostate cancer
• kidney failure (estimated GF \< 30 mL/Min)
• heart failure
• chronic atrophic gastritis
• pregnancy
• Healthy subjects:
• healthy
• 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

Sponsors & Collaborators

• University of Western Ontario, Canada: lead

Study Sites (1)

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

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Carcinoid Tumor

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stan Van Uum, MD PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

CA (1)