Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients (DIB-NET)
Primary Purpose
Neuroendocrine Tumors
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
Sponsored by
About this trial
This is an interventional screening trial for Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- The ARDEN NET Centre, ENETS Centre of Excellence
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ongoing fasted
intake of caffeine containing beverages
intake of 5 item English breakfast
Arm Description
ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min
10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min
10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03288402
First Posted
August 10, 2017
Last Updated
March 5, 2018
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03288402
Brief Title
Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients
Acronym
DIB-NET
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
January 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
double crossover (ongoing fasted; or caffeine containing beverages; of 5-item English breakfast)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ongoing fasted
Arm Type
Experimental
Arm Description
ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min
Arm Title
intake of caffeine containing beverages
Arm Type
Experimental
Arm Description
10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min
Arm Title
intake of 5 item English breakfast
Arm Type
Experimental
Arm Description
10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min
Intervention Type
Other
Intervention Name(s)
ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
Intervention Description
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
Primary Outcome Measure Information:
Title
changes in plasma CgA measurements related to intake of food or caffeine containing beverages, as compared to ongoing fasted state
Description
plasma CgA 0, 30, 60, 90, 120, 150 and 180 min
Time Frame
up to 180 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
- 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin O Weickert, Professor
Organizational Affiliation
The ARDEN NET Centre, ENETS CoE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Megan Symington, Dr
Organizational Affiliation
The ARDEN NET Centre, ENETS CoE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen Robbins, Dr
Organizational Affiliation
The ARDEN NET Centre, ENETS CoE
Official's Role
Principal Investigator
Facility Information:
Facility Name
The ARDEN NET Centre, ENETS Centre of Excellence
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=weickert+mo
Description
publication list MO Weickert
Learn more about this trial
Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients
We'll reach out to this number within 24 hrs