TuLip : Role of the Tumor Environment in Cancer-related Fat Loss (TuLip)
Primary Purpose
Cancer, Cachexia, Adipose Tissue
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nissen Fundoplication, cholecystectomy
Sponsored by
About this trial
This is an interventional basic science trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
- Male
- 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).
- Adults capable of expressing their wishes.
- Understanding French
Exclusion Criteria:
- 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.
- Women
- Adults unable to express their will.
- Not understanding French
- Patients participating in a clinical trial for a drug treatment.
Sites / Locations
- Cliniques universitaires Saint LucRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with BMI < 30 kg/m2
Arm Description
Collection of subcutaneous and visceral adipose tissue pieces of 1-2 cm3 during abdominal surgery procedures
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
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).
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)
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)
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.
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.
Full Information
NCT ID
NCT05128318
First Posted
October 14, 2021
Last Updated
November 21, 2022
Sponsor
Université Catholique de Louvain
Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT05128318
Brief Title
TuLip : Role of the Tumor Environment in Cancer-related Fat Loss
Acronym
TuLip
Official Title
Study of the Tumor-adipose Tissue Dialogue: Role of Tumor Acidosis in the Induction of Adipocyte Lipolysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cachexia, Adipose Tissue
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Collection of subcutaneous and visceral adipose tissue from patients with BMI < 30 kg/m2
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with BMI < 30 kg/m2
Arm Type
Experimental
Arm Description
Collection of subcutaneous and visceral adipose tissue pieces of 1-2 cm3 during abdominal surgery procedures
Intervention Type
Procedure
Intervention Name(s)
Nissen Fundoplication, cholecystectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 100 days after the adipose tissue collection"
Title
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.
Description
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.
Time Frame
Up to 100 days after the adipose tissue collection"
Secondary Outcome Measure Information:
Title
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
Description
Protein analyses by western-blot (arbitrary units).
Time Frame
Up to 2 years after the adipose tissue collection
Title
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
Description
Protein analyses by ELISA (mol/L or g/L).
Time Frame
Up to 2 years after the adipose tissue collection
Title
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
Description
Protein analyses via proteomic analyses (relative units).
Time Frame
Up to 2 years after the adipose tissue collection
Title
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
Description
Biochemical analyses (biochemical kits)
Time Frame
Up to 2 years after the adipose tissue collection
Title
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
Description
Metabolomic analyses (arbitrary units or mol/L)
Time Frame
Up to 2 years after the adipose tissue collection
Title
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
Description
Measurement of gene expression by RNA sequencing (in counts) of RNA extracted from these ex-vivo cultured human adipocytes.
Time Frame
Up to 2 years after the adipose tissue collection
Title
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
Description
Measurement of gene expression by RT-qPCR (in relative units) of RNA extracted from these ex-vivo cultured human adipocytes.
Time Frame
Up to 2 years after the adipose tissue collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Adults capable of expressing their wishes.
Understanding French
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Bindels, Professor
Phone
+32 (2) 764 73 37
Email
laure.bindels@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Camille Lefevre, PhD
Phone
+32 (2) 764 73 95
Email
ca.lefevre@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit Navez, Professor
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Bindels, Professor
Phone
+32 (2) 764 73 37
Email
laure.bindels@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Camille Lefevre, PhD
Phone
+32 (2) 764 73 95
Email
ca.lefevre@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Benoit Navez, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
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TuLip : Role of the Tumor Environment in Cancer-related Fat Loss
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