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
- Are there results?
- None posted in the registry
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
Show all 20Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples
- ClinicalTrials.gov ID
- NCT01216267
- Acronym / sponsor ID
- HSREB16279
- Conditions
- Neuroendocrine Carcinoma (Carcinoid)
- Keywords
- chromogranin A, neuroendocrine, carcinoid, Proton Pump Inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lansoprazole | Active comparator | Drug: Lansoprazolelansoprazole for 7 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- having neuro-endocrine disease
- healthy
Key exclusion criteria (20 listed)
- age below 18 or above 70 years
- prostate cancer
- kidney failure (estimated GF < 30 mL/Min)
- heart failure
- chronic atrophic gastritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LansoprazoleAlso: Prevacidlansoprazole 30 mg HS x 7 days | Drug | lansoprazole |
| lansoprazoleAlso: pravacidlanzoprazole 30 mg HS for 7 days | Drug | lansoprazole |
Primary outcome
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.
1 secondary outcome
Effect of PPI on chromogranin A concentration
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stan Van Uum, MD PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lansoprazole in people with Neuroendocrine Carcinoma (Carcinoid), run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chromogranin A concentration serum (time frame: single time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.