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Trial record 29 of 53 for:    somatostatin analogues | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03288402
Recruitment Status : Unknown
Verified March 2018 by University Hospitals Coventry and Warwickshire NHS Trust.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE August 10, 2017
First Posted Date  ICMJE September 20, 2017
Last Update Posted Date March 7, 2018
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date August 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
changes in plasma CgA measurements related to intake of food or caffeine containing beverages, as compared to ongoing fasted state [ Time Frame: 180 min ]
plasma CgA 0, 30, 60, 90, 120, 150 and 180 min
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: ongoing fasted
    ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min
    Intervention: Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
  • Experimental: intake of caffeine containing beverages
    10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min
    Intervention: Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
  • Experimental: intake of 5 item English breakfast
    10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min
    Intervention: Other: ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 15, 2017)
42
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date August 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03288402
Other Study ID Numbers  ICMJE MW165915/IRAS ID 197653
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospitals Coventry and Warwickshire NHS Trust
Study Sponsor  ICMJE University Hospitals Coventry and Warwickshire NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospitals Coventry and Warwickshire NHS Trust
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP