Study Results
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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RECRUITING
24 participants
OBSERVATIONAL
2022-08-01
2025-04-30
Brief Summary
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Detailed Description
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Hypothesis: FMT of cachectic patients with pancreas cancer, naïve of any anti-cancer treatment and artificial nutrition, into germ-free mice impairs weight gain, in contrast to FMT of non-cachectic patients and healthy controls.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cachectic patients with pancreatic cancer
Measurements and sample collection at one timepoint.
No interventions assigned to this group
Non-cachectic patients with pancreatic cancer
Measurements and sample collection at one timepoint.
No interventions assigned to this group
Healthy volunteers
Measurements and sample collection at one timepoint.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ≥18 years and
* Newly diagnosed of pancreatic adenocarcinoma (local or metastatic) and
* Tube feeding or parenteral nutrition ≤ 14 days
Cachectic pancreatic cancer patients (n=6)
* Cachexia according to the Fearon criteria 1: involuntary weight loss \>5% over the last 6 months, or any level of weight loss \>2% and a BMI \<20 kg/m2 or sarcopenia. Sarcopenia will be diagnosed by BIA (fat-free mass index is \<17 kg/m2 in men and \<15 kg/m2 in women) 81, and not by CT, as it is faster and can be performed at the bedside of the patient. Non-cachectic pancreatic cancer patients (n=6)
* Normal nutritional state: weight stability (± 2% of habitual weight) over the last 6 months, no anorexia before the diagnosis (appetite rating on a visual analogue scale of 100mm), no known impaired glucose tolerance.
Healthy matched subjects (n=12)
* ≥18 years and
* BMI between 18.5 and 30 kg/m2 and
* Absence of chronic or acute disease and
* Matching for gender and age (± 5 years) with an included pancreatic cancer patient
Exclusion Criteria
* Inability to give consent or
* Insufficient knowledge of project language (French, German) or
* Pancreatic adenocarcinoma already treated by chemo- or radiotherapy, or major surgery as duodenopancreatectomy or biliary diversion
* Known rheumatologic or immunologic diseases
* Therapeutic antibiotics or immunosuppressive drugs (for instance glucocorticoids, cytostatics, antibodies) in the 30 days preceding the inclusion
18 Years
ALL
Yes
Sponsors
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Genton Graf Laurence
OTHER
Responsible Party
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Genton Graf Laurence
Principal Investigator
Principal Investigators
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Laurence Genton Graf, Prof
Role: PRINCIPAL_INVESTIGATOR
Geneva University Hospitals (HUG)
Locations
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Geneva University Hospitals
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Laurence Genton Graf, Prof
Role: primary
Other Identifiers
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2022-00820
Identifier Type: -
Identifier Source: org_study_id