NCT05606523 Microbiota and Pancreatic Cancer Cachexia
| NCT ID | NCT05606523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Genton Graf Laurence |
| Condition | Pancreatic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2022-08-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Patients with pancreatic cancer (n=12) * ≥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: * \< 18 years or * 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
Contact & Investigator
Laurence Genton Graf, Prof
PRINCIPAL INVESTIGATOR
Geneva University Hospitals (HUG)
Frequently Asked Questions
Who can join the NCT05606523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05606523 currently recruiting?
Yes, NCT05606523 is actively recruiting participants. Contact the research team at laurence.genton@hcuge.ch for enrollment information.
Where is the NCT05606523 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT05606523 clinical trial?
NCT05606523 is sponsored by Genton Graf Laurence. The principal investigator is Laurence Genton Graf, Prof at Geneva University Hospitals (HUG). The trial plans to enroll 24 participants.
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