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

NCT ID: NCT05128318

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-16

Study Completion Date

2024-04-22

Brief Summary

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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

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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

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Cancer Cachexia Adipose Tissue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Collection of subcutaneous and visceral adipose tissue from patients with BMI \< 30 kg/m2
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients with BMI < 30 kg/m2

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

Group Type EXPERIMENTAL

Nissen Fundoplication, cholecystectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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), eventration, or parietal surgery .
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benoit Navez, Professor

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques universitaires Saint Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type RESULT
PMID: 38570069 (View on PubMed)

Other Identifiers

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TuLip

Identifier Type: -

Identifier Source: org_study_id

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