Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients

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.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The ARDEN NET Centre, ENETS Centre of Excellence

Coventry, CV2 2DX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast

Other

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 outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study 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)

Acronym: DIB-NET

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2022
First posted: Sep 20, 2017
Registry last updated: Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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