Neuroendocrine TumorsDIB-NETNCT03288402
Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients
A study testing ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast in people with Neuroendocrine Tumors, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
Measurement of plasma chromogranin A remains the most commonly used biomarkers for both screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours (GEP-NET), despite several limitations that include: lack of a reference CgA standard; wide variations depending on the used assay in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2017to 10 Feb 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GEP-NET patients:
- Confirmed diagnosis of NET
- Aged 18 or over
- Able to provide written informed consent
- Able to commit to 3 visits within a 4 week period
- Able to fast overnight
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- Able to adequately read/write/speak English
- CONTROLS:
- No known diagnosis of NET
- Aged 18 or over
- Able to provide written informed consent
- Able to commit to 3 visits within a 4 week period
- Able to fast overnight
- Able to adequately read/write/speak English
Who cannot join
- GEP-NET patients
- No confirmed diagnosis of a NET
- Under the age of 18
- Unable to provide written informed consent
- Pregnant women
- Any patients who are un well on the day of their routine appointment
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- Unable to fast overnight
- Unable to adequately read/write/speak English
- CONTROLS
- Confirmed diagnosis of NET
- Under the age of 18
- Unable to provide written informed consent
- Pregnant women
- Any patients who are un well on the day
- Unable to fast overnight
- Unable to adequately read/write/speak English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The ARDEN NET Centre, ENETS Centre of Excellence
Coventry, CV2 2DX
About this study
Official title: Investigation of the Effects of Breakfast or Caffeine Containing Beverages on the Measurement of Plasma Chromogranin A in Patients With Gastro-entero-pancreatic Neuroendocrine Tumours (GEP-NET)
Measurement of plasma chromogranin A remains the most commonly used biomarkers for both screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours (GEP-NET), despite several limitations that include: lack of a reference CgA standard; wide variations depending on the used assay in different laboratories; and varying sensitivity ranges from 60 to 90% with low specificity <50%, depending on the population studied.
Surprisingly, and to the best of our knowledge, only three studies with small numbers of participants have been published that have investigated possible effects of food intake on the measurement of CgA. Most have been performed in healthy controls or patients on treatment with proton pump inhibitors for chronic gastritis (up to n = 11 per group) but only one study has investigated patients with GEP-NET, where n = 6 patients with gastric NET were included.
In this study, the investigators aim to assess the time dependent effects of normally ingested diet (5-item English breakfast; or tea or coffee; or ongoing fasted state) on plasma chromogranin A measurements, using timed measurements over 180 min following an > 10 hours overnight fast, in a randomised double-crossover design. The investigators aimed to include 25 - 35 patients with a histologically confirmed diagnosis of a GEP-NET of varying primary tumour location, tumour stage, grade; and presence or absence of treatment with long acting somatostatin analogues; as well as 10 - 15 healthy controls. In an additional small subgroup of patients who are initiated on treatment with GLP-1 analogues i.e. for type 2 diabetes or obesity, the investigators aim to establish whether injection of GLP-1 analogues has any effects on plasma CgA measurements.
- Conditions
- Neuroendocrine Tumors
- Being tested
- ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfastOther
effects of ongoing fasted state; or intake caffeine containing beverages; or 5-item English breakfast on plasma CgA measurements, in series blood tests every 30 min over 180 min
| Study group | Role | What they receive |
|---|---|---|
| ongoing fasted | Experimental | ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min Receives: Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast |
| intake of caffeine containing beverages | Experimental | 10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min Receives: Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast |
| intake of 5 item English breakfast | Experimental | 10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min Receives: Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in plasma CgA measurements related to intake of food or caffeine containing beverages, as compared to ongoing fasted state
plasma CgA 0, 30, 60, 90, 120, 150 and 180 min
Measured: up to 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Feb 2017
- Primary completion10 Aug 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double crossover (ongoing fasted; or caffeine containing beverages; of 5-item English breakfast)
- Masking
- None (open label)
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin O Weickert, Professor, Study chair, The ARDEN NET Centre, ENETS CoEMegan Symington, Dr, Principal investigator, The ARDEN NET Centre, ENETS CoEHelen Robbins, Dr, Principal investigator, The ARDEN NET Centre, ENETS CoE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288402
- Sponsor's protocol ID
- MW165915/IRAS ID 197653
- Acronym
- DIB-NET
- Status last verified
- Jun 2024
- First submitted
- 10 Aug 2017
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Breakfast or Caffeine Containing Beverages on the Measurement of Plasma Chromogranin A in Patients With Gastro-entero-pancreatic Neuroendocrine Tumours (GEP-NET)
- ClinicalTrials.gov ID
- NCT03288402
- Acronym / sponsor ID
- DIB-NET / MW165915/IRAS ID 197653
- Conditions
- Neuroendocrine Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 20 Sep 2017 (actual)
- 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.
Measurement of plasma chromogranin A remains the most commonly used biomarkers for both screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours (GEP-NET), despite several limitations that include: lack of a reference CgA standard; wide variations depending on the used assay in different laboratories; and varying sensitivity ranges from 60 to 90% with low specificity <50%, depending on the population studied.
Surprisingly, and to the best of our knowledge, only three studies with small numbers of participants have been published that have investigated possible effects of food intake on the measurement of CgA. Most have been performed in healthy controls or patients on treatment with proton pump inhibitors for chronic gastritis (up to n = 11 per group) but only one study has investigated patients with GEP-NET, where n = 6 patients with gastric NET were included.
In this study, the investigators aim to assess the time dependent effects of normally ingested diet (5-item English breakfast; or tea or coffee; or ongoing fasted state) on plasma chromogranin A measurements, using timed measurements over 180 min following an > 10 hours overnight fast, in a randomised double-crossover design. The investigators aimed to include 25 - 35 patients with a histologically confirmed diagnosis of a GEP-NET of varying primary tumour location, tumour stage, grade; and presence or absence of treatment with long acting somatostatin analogues; as well as 10 - 15 healthy controls. In an additional small subgroup of patients who are initiated on treatment with GLP-1 analogues i.e. for type 2 diabetes or obesity, the investigators aim to establish whether injection of GLP-1 analogues has any effects on plasma CgA measurements.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- double crossover (ongoing fasted; or caffeine containing beverages; of 5-item English breakfast)
| Arm | Type | Receives |
|---|---|---|
| ongoing fasted | Experimental | Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfastongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min |
| intake of caffeine containing beverages | Experimental | Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min |
| intake of 5 item English breakfast | Experimental | Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Confirmed diagnosis of NET
- Aged 18 or over
- Able to provide written informed consent
- Able to commit to 3 visits within a 4 week period
- Able to fast overnight
Key exclusion criteria (16 listed)
- GEP-NET patients
- No confirmed diagnosis of a NET
- Under the age of 18
- Unable to provide written informed consent
- Pregnant women
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 |
|---|---|---|
| ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfasteffects of ongoing fasted state; or intake caffeine containing beverages; or 5-item English breakfast on plasma CgA measurements, in series blood tests every 30 min over 180 min | Other | intake of 5 item English breakfast, intake of caffeine containing beverages, ongoing fasted |
Primary outcome
changes in plasma CgA measurements related to intake of food or caffeine containing beverages, as compared to ongoing fasted state
Time frame: up to 180 min
plasma CgA 0, 30, 60, 90, 120, 150 and 180 min
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 20 Jun 2024.
- publication list MO WeickertLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Martin O Weickert, Professor study chair
The ARDEN NET Centre, ENETS CoE
Megan Symington, Dr principal investigator
The ARDEN NET Centre, ENETS CoE
Helen Robbins, Dr principal investigator
The ARDEN NET Centre, ENETS CoE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast in people with Neuroendocrine Tumors, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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 14 inclusion and 16 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 20 Jun 2024. 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 United Kingdom. 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?
changes in plasma CgA measurements related to intake of food or caffeine containing beverages, as compared to ongoing fasted state (time frame: up to 180 min). 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 20 Jun 2024.