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

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ClinicalTrials.gov Identifier: NCT03288402
Recruitment Status : Active, not recruiting
First Posted : September 20, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

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.


Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: double crossover (ongoing fasted; or caffeine containing beverages; of 5-item English breakfast)
Masking: None (Open Label)
Primary Purpose: Screening
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)
Actual Study Start Date : January 2017
Actual Primary Completion Date : August 3, 2017
Estimated Study Completion Date : January 31, 2020


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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288402


Locations
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United Kingdom
The ARDEN NET Centre, ENETS Centre of Excellence
Coventry, United Kingdom, CV2 2DX
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Investigators
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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

Additional Information:
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Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT03288402     History of Changes
Other Study ID Numbers: MW165915/IRAS ID 197653
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents