Neuroendocrine Carcinoma (Carcinoid)NCT01216267
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples
A study testing Lansoprazole in people with Neuroendocrine Carcinoma (Carcinoid), run by University of Western Ontario, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Carcinoma (Carcinoid)
- What is being tested?
- Lansoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Jan 2012
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having neuro-endocrine disease
- healthy
Who cannot join
- age below 18 or above 70 years
- prostate cancer
- kidney failure (estimated GF < 30 mL/Min)
- heart failure
- chronic atrophic gastritis
- pregnancy
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- Healthy subjects:
- 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 locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Center and St. Joseph's Health Care
London, Ontario, N6A 4V2
About this study
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.
Read the detailed description
Patient group: patients with neuroendocrine tumors (active or inactive) Healthy volunteers
- Conditions
- Neuroendocrine Carcinoma (Carcinoid)
- Being tested
- Lansoprazole
- Keywords
- chromogranin A, neuroendocrine, carcinoid, Proton Pump Inhibitor
- Medical subject headings
- Carcinoma, Neuroendocrine, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Also called Prevacid
lansoprazole 30 mg HS x 7 days
lansoprazoleDrug
Also called pravacid
lanzoprazole 30 mg HS for 7 days
| Study group | Role | What they receive |
|---|---|---|
| lansoprazole | Active comparator | lansoprazole for 7 days Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single time
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Carcinoma (Carcinoid)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaus H. van Uum, University of Western Ontario, Canada
- Investigators
- Stan Van Uum, MD PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216267
- Sponsor's protocol ID
- HSREB16279
- Status last verified
- Jan 2013
- First submitted
- 5 Oct 2010
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No