TuLip : Role of the Tumor Environment in Cancer-related Fat Loss

Sponsor
Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT05128318
Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
39
1
1
14
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Nissen Fundoplication, cholecystectomy
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Collection of subcutaneous and visceral adipose tissue from patients with BMI < 30 kg/m2Collection of subcutaneous and visceral adipose tissue from patients with BMI < 30 kg/m2
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Study of the Tumor-adipose Tissue Dialogue: Role of Tumor Acidosis in the Induction of Adipocyte Lipolysis
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with BMI < 30 kg/m2

Collection of subcutaneous and visceral adipose tissue pieces of 1-2 cm3 during abdominal surgery procedures

Procedure: Nissen Fundoplication, cholecystectomy
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.

Outcome Measures

Primary Outcome Measures

  1. 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 [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.

  2. 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. [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.

Secondary Outcome Measures

  1. 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 [Up to 2 years after the adipose tissue collection]

    Protein analyses by western-blot (arbitrary units).

  2. 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 [Up to 2 years after the adipose tissue collection]

    Protein analyses by ELISA (mol/L or g/L).

  3. 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 [Up to 2 years after the adipose tissue collection]

    Protein analyses via proteomic analyses (relative units).

  4. 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 [Up to 2 years after the adipose tissue collection]

    Biochemical analyses (biochemical kits)

  5. 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 [Up to 2 years after the adipose tissue collection]

    Metabolomic analyses (arbitrary units or mol/L)

  6. 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 [Up to 2 years after the adipose tissue collection]

    Measurement of gene expression by RNA sequencing (in counts) of RNA extracted from these ex-vivo cultured human adipocytes.

  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 RT-qPCR [Up to 2 years after the adipose tissue collection]

    Measurement of gene expression by RT-qPCR (in relative units) of RNA extracted from these ex-vivo cultured human adipocytes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques universitaires Saint Luc Brussel Belgium 1200

Sponsors and Collaborators

  • Université Catholique de Louvain
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Benoit Navez, Professor, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT05128318
Other Study ID Numbers:
  • TuLip
First Posted:
Nov 22, 2021
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022