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

University of Western Ontario, Canada

Status: Completed

Conditions: Neuroendocrine Carcinoma (Carcinoid)

Treatments: Drug: Lansoprazole; Drug: lansoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01216267

HSREB16279

Details and patient eligibility

About

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.

Full description

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

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

lansoprazole

Active Comparator group

Description:

lansoprazole for 7 days

Treatment:

Drug: Lansoprazole