Microbiota and Pancreatic Cancer Cachexia

NCT05606523 | Recruiting

• 1 other identifier: 2022-00820
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Microbiota; Cachexia

Outcome Measures

Primary Outcomes (1)

• Body weight changes in mice after fecal material transplantation.

  Body weight (g)

  Between days 0 and 30

Secondary Outcomes (28)

• Differences in fecal microbiota

  at diagnosis

• Body weight

  at diagnosis

• Waist-to-hip ratio

  at diagnosis

• Fat mass

  at diagnosis

• Fat-free mass

  at diagnosis

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Genton Graf Laurence: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

feces, saliva, blood

MeSH Terms

Conditions

Pancreatic Neoplasms; Cachexia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Laurence Genton Graf, Prof

  Geneva University Hospitals (HUG)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Genton Graf, Prof

CONTACT

+41 22 3729344; laurence.genton@hcuge.ch

Alexandra Hemmer, MSc

CONTACT

+41795530491; alexandra.hemmer@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: November 4, 2022
• Study Start: August 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CH (1)