CancerTuLipNCT05128318
TuLip : Role of the Tumor Environment in Cancer-related Fat Loss
A study testing Nissen Fundoplication, cholecystectomy in people with Cancer and Cachexia, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Cancer cachexia is defined as a weight loss of more than 5% over the last 6 months, a loss of body fat and muscle atrophy. It is found in 80% of patients with advanced cancer. In this context, white adipose tissue is a particularly interesting target since its depletion precedes the loss of muscle mass, and is… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cancer, Cachexia, Adipose Tissue
- What is being tested?
- Nissen Fundoplication, cholecystectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Nov 2022to 22 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Programmed surgeries in the abdominal area in the Department of Surgery and Transplantation at Cliniques Universitaires Saint-Luc under the supervision of Prof. Dr. Benoit Navez.
- Hospitalization in the context of surgery
- Caucasian
- Age between 18 and 60 years (included).
- Body mass index less than 30 and greater than or equal to 18.5
- Programmed Nissen fundoplication (to treat hiatal hernia and gastroesophageal reflux) or cholecystectomy (to treat vesicular lithiasis), eventration, or parietal surgery .
- Adults capable of expressing their wishes.
- Understanding French
Who cannot join
- Body mass index below 18.5 and above 30.
- Patients with cancer, infection, autoimmune or inflammatory disease, metabolic syndrome.
- Patients with beta-blockers, hypoglycemics, anti-diabetics, hypolipidemics.
- Adults unable to express their will.
- Not understanding French
- Patients participating in a clinical trial for a drug treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Tumor-adipose Tissue Dialogue: Role of Tumor Acidosis in the Induction of Adipocyte Lipolysis
Cancer cachexia is defined as a weight loss of more than 5% over the last 6 months, a loss of body fat and muscle atrophy. It is found in 80% of patients with advanced cancer. In this context, white adipose tissue is a particularly interesting target since its depletion precedes the loss of muscle mass, and is sufficient to induce a decrease in the response to anti-cancer treatments and in the survival of patients.
This cachexia is associated with advanced tumors that present acidosis and metastasis. In this clinical study the investigators would like explore the acid environment effect on the human adipose tissue depletion and more specifically on adipocyte lipolysis.
The main objective of the "TuLip" clinical study is therefore to validate in human subcutaneous and visceral adipocytes that factors secreted by tumor cells cultivated in acid tumor environment stimulate the release of lipids from adipose tissue. Adipocytes retrieves from this study will also be used to validate identified potential lipolytic factors derived from these cells.
Read the detailed description
This study is a monocentric clinical study. Patients with BMI < 30 kg/m2 will be recruited in the context of programmed abdominal surgery. In this context, subcutaneous and visceral adipose tissue pieces (1-2 cm3) will be collected to explore the lypolytic response of adipocytes ex-vivo to factors secreted by human cancer cell lines.
- Conditions
- Cancer, Cachexia, Adipose Tissue
- Being tested
- Nissen Fundoplication, cholecystectomy
- Medical subject headings
- Neoplasms, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nissen Fundoplication, cholecystectomyProcedure or surgery
Collection of adipose tissue pieces in the context of programmed abdominal surgery to treat to treat hiatal hernia, gastroesophageal reflux or vesicular lithiasis. During the surgery treatment, adipose tissue of 1-2 cm3 will be collected for the protocol by laparoscopy by the surgeon in charge of the procedures.
| Study group | Role | What they receive |
|---|---|---|
| Patients with BMI < 30 kg/m2 | Experimental | Collection of subcutaneous and visceral adipose tissue pieces of 1-2 cm3 during abdominal surgery procedures Receives: Procedure: Nissen Fundoplication, cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the lipolytic response of adipocytes isolated from human visceral and subcutaneous adipose tissue to factors derived from cancer cells in acid environment by the glycerol measurement
Measure ex-vivo of the lipolysis of subcutaneous and visceral adipocytes in the presence of factors derived from cancer cells. The lipolysis will be assessed by the measure of glycerol (in mol/L) released by adipocytes.
Measured: Up to 100 days after the adipose tissue collection"
Evaluation of the lipolytic response of adipocytes isolated from human visceral and subcutaneous adipose tissue to factors derived from cancer cells in acid environment by the fatty acid measurement.
Measure ex-vivo of the lipolysis of subcutaneous and visceral adipocytes in the presence of factors derived from cancer cells. The lipolysis will be assessed by the measure of free fatty acids (in mol/L) released by adipocytes.
Measured: Up to 100 days after the adipose tissue collection"
Secondary outcomes (7)
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by western-blot
Protein analyses by western-blot (arbitrary units).
Measured: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by ELISA
Protein analyses by ELISA (mol/L or g/L).
Measured: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by proteomic analyses
Protein analyses via proteomic analyses (relative units).
Measured: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by biochemical analyses
Biochemical analyses (biochemical kits)
Measured: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by metabolomic analyses
Metabolomic analyses (arbitrary units or mol/L)
Measured: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by RNA sequencing
Measurement of gene expression by RNA sequencing (in counts) of RNA extracted from these ex-vivo cultured human adipocytes.
Measured: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by RT-qPCR
Measurement of gene expression by RT-qPCR (in relative units) of RNA extracted from these ex-vivo cultured human adipocytes.
Measured: Up to 2 years after the adipose tissue collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start16 Nov 2022
- Primary completion18 Jul 2023
- Study completion22 Apr 2024
Why it stopped: Limited number of recruited patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Collection of subcutaneous and visceral adipose tissue from patients with BMI \< 30 kg/m2
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Navez, Professor, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128318
- Sponsor's protocol ID
- TuLip
- Acronym
- TuLip
- Status last verified
- May 2024
- First submitted
- 14 Oct 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lefevre C, Thibaut MM, Loumaye A, Thissen JP, Neyrinck AM, Navez B, Delzenne NM, Feron O, Bindels LB. Tumoral acidosis promotes adipose tissue depletion by fostering adipocyte lipolysis. Mol Metab. 2024 May;83:101930. doi: 10.1016/j.molmet.2024.101930. Epub 2024 Apr 1.
PubMed 38570069
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Tumor-adipose Tissue Dialogue: Role of Tumor Acidosis in the Induction of Adipocyte Lipolysis
- ClinicalTrials.gov ID
- NCT05128318
- Acronym / sponsor ID
- TuLip / TuLip
- Conditions
- Cancer, Cachexia, Adipose Tissue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited number of recruited patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 22 Nov 2021 (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.
Cancer cachexia is defined as a weight loss of more than 5% over the last 6 months, a loss of body fat and muscle atrophy. It is found in 80% of patients with advanced cancer. In this context, white adipose tissue is a particularly interesting target since its depletion precedes the loss of muscle mass, and is sufficient to induce a decrease in the response to anti-cancer treatments and in the survival of patients.
This cachexia is associated with advanced tumors that present acidosis and metastasis. In this clinical study the investigators would like explore the acid environment effect on the human adipose tissue depletion and more specifically on adipocyte lipolysis.
The main objective of the "TuLip" clinical study is therefore to validate in human subcutaneous and visceral adipocytes that factors secreted by tumor cells cultivated in acid tumor environment stimulate the release of lipids from adipose tissue. Adipocytes retrieves from this study will also be used to validate identified potential lipolytic factors derived from these cells.
Detailed description
This study is a monocentric clinical study. Patients with BMI < 30 kg/m2 will be recruited in the context of programmed abdominal surgery. In this context, subcutaneous and visceral adipose tissue pieces (1-2 cm3) will be collected to explore the lypolytic response of adipocytes ex-vivo to factors secreted by human cancer cell lines.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Collection of subcutaneous and visceral adipose tissue from patients with BMI < 30 kg/m2
| Arm | Type | Receives |
|---|---|---|
| Patients with BMI < 30 kg/m2 | Experimental | Procedure: Nissen Fundoplication, cholecystectomyCollection of subcutaneous and visceral adipose tissue pieces of 1-2 cm3 during abdominal surgery procedures |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Programmed surgeries in the abdominal area in the Department of Surgery and Transplantation at Cliniques Universitaires Saint-Luc under the supervision of Prof. Dr. Benoit Navez.
- Hospitalization in the context of surgery
- Caucasian
- Age between 18 and 60 years (included).
- Body mass index less than 30 and greater than or equal to 18.5
Key exclusion criteria (6 listed)
- Body mass index below 18.5 and above 30.
- Patients with cancer, infection, autoimmune or inflammatory disease, metabolic syndrome.
- Patients with beta-blockers, hypoglycemics, anti-diabetics, hypolipidemics.
- Adults unable to express their will.
- Not understanding French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nissen Fundoplication, cholecystectomyCollection of adipose tissue pieces in the context of programmed abdominal surgery to treat to treat hiatal hernia, gastroesophageal reflux or vesicular lithiasis. During the surgery treatment, adipose tissue of 1-2 cm3 will be collected for the protocol by laparoscopy by the surgeon in charge of the procedures. | Procedure or surgery | Patients with BMI < 30 kg/m2 |
Primary outcome
Evaluation of the lipolytic response of adipocytes isolated from human visceral and subcutaneous adipose tissue to factors derived from cancer cells in acid environment by the glycerol measurement
Time frame: Up to 100 days after the adipose tissue collection"
Measure ex-vivo of the lipolysis of subcutaneous and visceral adipocytes in the presence of factors derived from cancer cells. The lipolysis will be assessed by the measure of glycerol (in mol/L) released by adipocytes.
Evaluation of the lipolytic response of adipocytes isolated from human visceral and subcutaneous adipose tissue to factors derived from cancer cells in acid environment by the fatty acid measurement.
Time frame: Up to 100 days after the adipose tissue collection"
Measure ex-vivo of the lipolysis of subcutaneous and visceral adipocytes in the presence of factors derived from cancer cells. The lipolysis will be assessed by the measure of free fatty acids (in mol/L) released by adipocytes.
7 secondary outcomes
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by western-blot
Time frame: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by ELISA
Time frame: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by proteomic analyses
Time frame: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by biochemical analyses
Time frame: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by metabolomic analyses
Time frame: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by RNA sequencing
Time frame: Up to 2 years after the adipose tissue collection
Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by RT-qPCR
Time frame: Up to 2 years after the adipose tissue collection
Results and safety
The study was stopped early (reason given: Limited number of recruited patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Results publication: PubMed 38570069Lefevre C, Thibaut MM, Loumaye A, Thissen JP, Neyrinck AM, Navez B, Delzenne NM, Feron O, Bindels LB. Tumoral acidosis promotes adipose tissue depletion by fostering adipocyte lipolysis. Mol Metab. 2024 May;83:101930. doi: 10.1016/j.molmet.2024.101930. Epub 2024 Apr 1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Benoit Navez, Professor principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nissen Fundoplication, cholecystectomy in people with Cancer and Cachexia, run by Université Catholique de Louvain at 1 site in Belgium.
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 8 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: stopped early, as of the sponsor's last update on 9 May 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 Belgium. 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?
The study was stopped early (reason given: Limited number of recruited patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the lipolytic response of adipocytes isolated from human visceral and subcutaneous adipose tissue to factors derived from cancer cells in acid environment by the glycerol measurement (time frame: Up to 100 days after the adipose tissue collection"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128318, which also lists 1 linked publication.
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 9 May 2024.