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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2022-02-10

Brief Summary

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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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Detailed Description

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Conditions

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Neuroendocrine Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

double crossover (ongoing fasted; or caffeine containing beverages; of 5-item English breakfast)

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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ongoing fasted

ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min

Group Type EXPERIMENTAL

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

Intervention Type 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

intake of caffeine containing beverages

10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min

Group Type EXPERIMENTAL

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

Intervention Type 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

intake of 5 item English breakfast

10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes