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Completed

NCT Number: NCT01216267

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

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.

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Key information

Conditions

Neuroendocrine Carcinoma (Carcinoid) Adenocarcinoma Carcinoid Tumor Carcinoma Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

London, Ontario, N6A 4V2, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lansoprazole

Drug

lansoprazole 30 mg HS x 7 days

Other names: Prevacid

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Western Ontario, Canada

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2010
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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