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NCT05606523Recruiting

Microbiota and Pancreatic Cancer Cachexia

Can Fecal Microbiota Transplantation of Cachectic Patients with Pancreas Cancer Impair Body Weight Gain in Germ-free Mice? the EXTRA Study

Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
24 (estimated)
First submitted
25 Aug 2022
Start date
1 Aug 2022
Primary completion date
30 Apr 2025
Lead sponsor
Genton Graf Laurence
NCT number
NCT05606523

What you commit to

  • Study type: Observational
  • Planned participants: 24
  • From 1 Aug 2022 to the primary completion date, 30 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pancreatic adenocarcinoma already treated by chemo- or radiotherapy, or major surgery as duodenopancreatectomy or biliary diversion
  • Therapeutic antibiotics or immunosuppressive drugs (for instance glucocorticoids, cytostatics, antibodies) in the 30 days preceding the inclusion

Other illness

  • Known rheumatologic or immunologic diseases

Age

  • \< 18 years or

Other

  • Inability to give consent or
  • Insufficient knowledge of project language (French, German) or

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Geneva University Hospitals
Coordinator of this site? Confirm its status
GenevaSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.