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This monocentric study aims at evaluating the effects of fecal microbiota transplantation from newly diagnosed cachectic and non-cachectic pancreatic cancer patients, and healthy volunteers on several cachexia-related parameters of germ-free mice.
Aim: Evaluating the effects of fecal microbiota transplantation (FMT) from 6 newly diagnosed cachectic and 6 non-cachectic pancreatic cancer patients, and 12 healthy age-and sex-matched volunteers on several cachexia-related parameters of 96 germ-free mice (4 per donor) over a 30-day period. The fecal material of all 12 pancreatic cancer patients will be collected at diagnosis before any cancer treatment onset.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cachectic patients with pancreatic cancer | Measurements and sample collection at one timepoint. | ||
| Non-cachectic patients with pancreatic cancer | Measurements and sample collection at one timepoint. | ||
| Healthy volunteers | Measurements and sample collection at one timepoint. |
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| Measure | Description | Time Frame |
|---|---|---|
| Body weight changes in mice after fecal material transplantation. | Body weight (g) | Between days 0 and 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in fecal microbiota | by 16S rRNA gene amplicon sequencing and functional profiles by metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Body weight |
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Inclusion Criteria:
Patients with pancreatic cancer (n=12)
Cachectic pancreatic cancer patients (n=6)
Healthy matched subjects (n=12)
Exclusion Criteria:
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We will consider the fecal samples of 12 patients at diagnosis of pancreatic cancer including 6 patients with cachexia and 6 patients without cachexia, and therefore naïve of any anti-cancer treatment and artificial nutritional support. We will also include 12 healthy volunteers matched for gender and age (± 5 years) with the pancreatic cancer patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence Genton Graf, Prof | Contact | +41 22 3729344 | laurence.genton@hcuge.ch | |
| Alexandra Hemmer, MSc | Contact | +41795530491 | alexandra.hemmer@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Laurence Genton Graf, Prof | Geneva University Hospitals (HUG) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Recruiting | Geneva | 1211 | Switzerland |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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feces, saliva, blood
in kilograms between cachectic patients non-cachectic patients and healthy volunteers
| at diagnosis |
| Waist-to-hip ratio | waist circumference (cm) and hip circumference (cm) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Fat mass | by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Fat-free mass | by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Muscle mass | surfaces of the paraspinal and abdominal wall muscles at the level of L3-L4 disk space by CT for pancreatic cancer patients | at diagnosis |
| Nutritional intake | by 3-day food diary between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Resting energy expenditure (REE) | by indirect calorimetry between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by visual analogue scale ranging from 0 to 100 mm between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma ghrelin between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma leptin between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma glucagon-like peptide-1 (GLP-1) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma neuropeptide Y between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Appetite | by fasting level of plasma cholecystokinin between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Homeostatic model assessment (HOMA)-score | by fasting glycemia (mmol/l) and fasting insulinemia (mU/ml)) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Glycemia | by fasting glycemia (mmol/l) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Insulinemia | by fasting insulinemia (mU/ml) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Physical function | by handgrip strength between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Physical activity | by the International Physical Activity Questionnaire (IPAQ) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Quality of life | by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC QLQ-C30) between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Mortality | by tumor progression between cachectic patients non-cachectic patients | at diagnosis |
| Oral microbiota | by 16SrRNA gene amplicon sequencing and metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Epithelial permeability | by fasting levels of plasma zonulin between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Epithelial permeability | by fasting levels of plasma lipopolysaccharide-binding protein between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| Epithelial permeability | by fasting levels of plasma glucagon-like peptide-2 between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| GALT function and systemic inflammation | by fasting plasma level of C-reactive protein (CRP) and cytokines between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| GALT function and systemic inflammation | by peripheral blood T regulatory cells (Tregs) levels and phenotype between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| GALT function and systemic inflammation | by myeloid derived suppressor cells (MDSC) levels and phenotype between cachectic patients non-cachectic patients and healthy volunteers | at diagnosis |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |