Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients (DIB-NET)

March 5, 2018 updated by: University Hospitals Coventry and Warwickshire NHS Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • The ARDEN NET Centre, ENETS Centre of Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ongoing fasted
ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min
Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
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
Experimental: intake of caffeine containing beverages
10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min
Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
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
Experimental: intake of 5 item English breakfast
10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min
Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 180 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Investigators

  • Study Chair: Martin O Weickert, Professor, The ARDEN NET Centre, ENETS CoE
  • Principal Investigator: Megan Symington, Dr, The ARDEN NET Centre, ENETS CoE
  • Principal Investigator: Helen Robbins, Dr, The ARDEN NET Centre, ENETS CoE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

August 3, 2017

Study Completion (Anticipated)

January 31, 2020

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (Actual)

September 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MW165915/IRAS ID 197653

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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