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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ongoing fasted | Experimental | ongoing fasted following 10 h overnight fast; series blood samples CgA over 180 min |
|
| intake of caffeine containing beverages | Experimental | 10 h overnight fast; intake of caffeine containing beverages; series blood samples CgA over 180 min |
|
| intake of 5 item English breakfast | Experimental | 10 h overnight fast; intake of 5-item English breakfast; series blood samples CgA over 180 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
GEP-NET patients:
CONTROLS:
Exclusion Criteria:
- GEP-NET patients
CONTROLS
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The ARDEN NET Centre, ENETS Centre of Excellence | Coventry | CV2 2DX | United Kingdom |
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| Label | URL |
|---|---|
| publication list MO Weickert | View source |
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double crossover (ongoing fasted; or caffeine containing beverages; of 5-item English breakfast)
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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