Pancreatic CancerEXTRANCT05606523
Microbiota and Pancreatic Cancer Cachexia
An observational study of Pancreatic Cancer and Microbiota, run by Genton Graf Laurence at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Microbiota, Cachexia
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1211
Laurence Genton Graf, Prof
About this study
Official title: Can Fecal Microbiota Transplantation of Cachectic Patients with Pancreas Cancer Impair Body Weight Gain in Germ-free Mice? the EXTRA Study
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.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer, Microbiota, Cachexia
- Medical subject headings
- Pancreatic Neoplasms, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight changes in mice after fecal material transplantation.
Body weight (g)
Measured: Between days 0 and 30
Secondary outcomes (28)
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
Measured: at diagnosis
Body weight
in kilograms between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Waist-to-hip ratio
waist circumference (cm) and hip circumference (cm) between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Fat mass
by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Fat-free mass
by bioelectrical impedance analysis (BIA) between cachectic patients non-cachectic patients and healthy volunteers
Measured: 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
Measured: at diagnosis
Nutritional intake
by 3-day food diary between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Resting energy expenditure (REE)
by indirect calorimetry between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Appetite
by visual analogue scale ranging from 0 to 100 mm between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Appetite
by fasting level of plasma ghrelin between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Appetite
by fasting level of plasma leptin between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Appetite
by fasting level of plasma glucagon-like peptide-1 (GLP-1) between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Appetite
by fasting level of plasma neuropeptide Y between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Appetite
by fasting level of plasma cholecystokinin between cachectic patients non-cachectic patients and healthy volunteers
Measured: 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
Measured: at diagnosis
Glycemia
by fasting glycemia (mmol/l) between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Insulinemia
by fasting insulinemia (mU/ml) between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Physical function
by handgrip strength between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Physical activity
by the International Physical Activity Questionnaire (IPAQ) between cachectic patients non-cachectic patients and healthy volunteers
Measured: 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
Measured: at diagnosis
Mortality
by tumor progression between cachectic patients non-cachectic patients
Measured: at diagnosis
Oral microbiota
by 16SrRNA gene amplicon sequencing and metagenomic sequencing between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Epithelial permeability
by fasting levels of plasma zonulin between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Epithelial permeability
by fasting levels of plasma lipopolysaccharide-binding protein between cachectic patients non-cachectic patients and healthy volunteers
Measured: at diagnosis
Epithelial permeability
by fasting levels of plasma glucagon-like peptide-2 between cachectic patients non-cachectic patients and healthy volunteers
Measured: 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
Measured: 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
Measured: 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
Measured: at diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Aug 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genton Graf Laurence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Genton Graf Laurence, University Hospital, Geneva
- Investigators
- Laurence Genton Graf, Prof, Principal investigator, Geneva University Hospitals (HUG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606523
- Sponsor's protocol ID
- 2022-00820
- Acronym
- EXTRA
- Status last verified
- Dec 2024
- First submitted
- 25 Aug 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Fecal Microbiota Transplantation of Cachectic Patients with Pancreas Cancer Impair Body Weight Gain in Germ-free Mice? the EXTRA Study
- ClinicalTrials.gov ID
- NCT05606523
- Acronym / sponsor ID
- EXTRA / 2022-00820
- Conditions
- Pancreatic Cancer, Microbiota, Cachexia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Genton Graf LaurenceUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (6 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight changes in mice after fecal material transplantation.
Time frame: Between days 0 and 30
Body weight (g)
28 secondary outcomes
Differences in fecal microbiota
Time frame: at diagnosis
Body weight
Time frame: at diagnosis
Waist-to-hip ratio
Time frame: at diagnosis
Fat mass
Time frame: at diagnosis
Fat-free mass
Time frame: at diagnosis
Muscle mass
Time frame: at diagnosis
Nutritional intake
Time frame: at diagnosis
Resting energy expenditure (REE)
Time frame: at diagnosis
Appetite
Time frame: at diagnosis
Appetite
Time frame: at diagnosis
Appetite
Time frame: at diagnosis
Appetite
Time frame: at diagnosis
Appetite
Time frame: at diagnosis
Appetite
Time frame: at diagnosis
Homeostatic model assessment (HOMA)-score
Time frame: at diagnosis
Glycemia
Time frame: at diagnosis
Insulinemia
Time frame: at diagnosis
Physical function
Time frame: at diagnosis
Physical activity
Time frame: at diagnosis
Quality of life
Time frame: at diagnosis
Mortality
Time frame: at diagnosis
Oral microbiota
Time frame: at diagnosis
Epithelial permeability
Time frame: at diagnosis
Epithelial permeability
Time frame: at diagnosis
Epithelial permeability
Time frame: at diagnosis
GALT function and systemic inflammation
Time frame: at diagnosis
GALT function and systemic inflammation
Time frame: at diagnosis
GALT function and systemic inflammation
Time frame: at diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurence Genton Graf, Prof principal investigator
Geneva University Hospitals (HUG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Microbiota, run by Genton Graf Laurence at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence Genton Graf, Prof (+41 22 3729344, laurence.genton@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight changes in mice after fecal material transplantation. (time frame: Between days 0 and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.