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

NCT03288402 | Completed

• 1 other identifier: MW165915/IRAS ID 197653
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• 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

  up to 180 min

Study Arms (3)

ongoing fasted

EXPERIMENTAL

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

intake of caffeine containing beverages

EXPERIMENTAL

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

intake of 5 item English breakfast

EXPERIMENTAL

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

Interventions

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

intake of 5 item English breakfast; intake of caffeine containing beverages; ongoing fasted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

The ARDEN NET Centre, ENETS Centre of Excellence

Coventry, CV2 2DX, United Kingdom

Location

Related Links

• publication list MO Weickert

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin O Weickert, Professor

  The ARDEN NET Centre, ENETS CoE

  STUDY CHAIR

• Megan Symington, Dr

  The ARDEN NET Centre, ENETS CoE

  PRINCIPAL INVESTIGATOR

• Helen Robbins, Dr

  The ARDEN NET Centre, ENETS CoE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: September 20, 2017
• Study Start: February 1, 2017
• Primary Completion: August 10, 2021
• Study Completion: February 10, 2022
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)