Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions

NCT ID: NCT04389112

Last Updated: 2022-11-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2022-12-31

Brief Summary

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Skin carcinomas are the most frequent cancers in the world, including basal cell carcinomas and cutaneous squamous cell carcinoma (cSCCs), with more than 60.000 new annual cases in France. Their incidence increases mainly due to ultraviolet (UV) exposure and population ageing. Then from 1994 to 2006, the incidence of cSCC has increased by 300%. CSCCs typically manifests as a spectrum from a precursor actinic keratosis (AK) - possible spontaneous regression at this stage- to in situ cSCC invasive cSCC and finally metastatic cSCC.

Detailed Description

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Although growing evidence indicates that bioenergetic metabolism plays an important role in the progression of tumorigenesis, little information is available on the contribution of reprogramming of energy metabolism in cancer initiation and how it influences further the bioenergetic behavior of tumors.

By applying a quantitative proteomic approach, the consortium has recently found that specific metabolic modifications precede cSCC.

This study will investigate the role of energy metabolism in malignant transformation of premalignant skin lesions into cSCC, and in cSCC progression, with correlation with clinical characteristics and metastatic outcomes. Using several cutting-edge technologies in human samples, the team will evaluate whether targeting energy metabolism has the potential to be used as curative treatments for cSCC and whether pre-determined metabolic alterations could be exploited as new preventive strategies. These modifications in energy metabolism could be used as prognostic and diagnostic biomarkers.

Conditions

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Cutaneous Squamous Cell Carcinoma Basal Cell Carcinomas

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with actinic keratoses

Group Type EXPERIMENTAL

biopsy

Intervention Type OTHER

Skin biopsies will be performed according to standard practices in the usual aseptic conditions, the operator wearing sterile gloves. A circular knife 3 mm will be used. Procedure interventions do not involve a drug or a device.

patients with squamous cell carcinoma in situ

Group Type EXPERIMENTAL

biopsy

Intervention Type OTHER

Skin biopsies will be performed according to standard practices in the usual aseptic conditions, the operator wearing sterile gloves. A circular knife 3 mm will be used. Procedure interventions do not involve a drug or a device.

patients with squamous cell carcinomas

Group Type EXPERIMENTAL

biopsy

Intervention Type OTHER

Skin biopsies will be performed according to standard practices in the usual aseptic conditions, the operator wearing sterile gloves. A circular knife 3 mm will be used. Procedure interventions do not involve a drug or a device.

patient with invasive metastates

Group Type EXPERIMENTAL

biopsy

Intervention Type OTHER

Skin biopsies will be performed according to standard practices in the usual aseptic conditions, the operator wearing sterile gloves. A circular knife 3 mm will be used. Procedure interventions do not involve a drug or a device.

Interventions

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biopsy

Skin biopsies will be performed according to standard practices in the usual aseptic conditions, the operator wearing sterile gloves. A circular knife 3 mm will be used. Procedure interventions do not involve a drug or a device.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Every patient with suspected lesion :

* AK,
* in situ cSCC,
* infiltrative cSSC
* cSCC with recurrent disease
* cSCC with cutaneous metastases.
* Patients 18 years of age or older,
* Patients with suspected AK or BCC lesions (in situ, infiltrating or metastatic),
* Patient able to sign a consent form,
* Patient affiliated with a Social Security system.

Exclusion Criteria

* Prior systemic treatment such as checkpoint inhibitors or chemotherapy.
* Patients with cSCC or AK localized on visible zone of the face or folds
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie BEYLOT-BARRY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Hôpital Saint-André - CHU de Bordeaux

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie BEYLOT-BARRY, MD, PhD

Role: CONTACT

+335 57 82 25 00

Léa DOUSSET, MD

Role: CONTACT

+335 57 82 25 00

Facility Contacts

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Marie BEYLOT-BARRY, MD, PhD

Role: primary

+335 57 82 25 00

Christine ALFARO

Role: backup

+335 56 82 06 55

References

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Obre E, Rossignol R. Emerging concepts in bioenergetics and cancer research: metabolic flexibility, coupling, symbiosis, switch, oxidative tumors, metabolic remodeling, signaling and bioenergetic therapy. Int J Biochem Cell Biol. 2015 Feb;59:167-81. doi: 10.1016/j.biocel.2014.12.008. Epub 2014 Dec 24.

Reference Type BACKGROUND
PMID: 25542180 (View on PubMed)

Hosseini M, Dousset L, Mahfouf W, Serrano-Sanchez M, Redonnet-Vernhet I, Mesli S, Kasraian Z, Obre E, Bonneu M, Claverol S, Vlaski M, Ivanovic Z, Rachidi W, Douki T, Taieb A, Bouzier-Sore AK, Rossignol R, Rezvani HR. Energy Metabolism Rewiring Precedes UVB-Induced Primary Skin Tumor Formation. Cell Rep. 2018 Jun 19;23(12):3621-3634. doi: 10.1016/j.celrep.2018.05.060.

Reference Type BACKGROUND
PMID: 29925003 (View on PubMed)

Hosseini M, Dousset L, Michon P, Mahfouf W, Muzotte E, Bergeron V, Bortolotto D, Rossignol R, Moisan F, Taieb A, Bouzier-Sore AK, Rezvani HR. UVB-induced DHODH upregulation, which is driven by STAT3, is a promising target for chemoprevention and combination therapy of photocarcinogenesis. Oncogenesis. 2019 Sep 24;8(10):52. doi: 10.1038/s41389-019-0161-z.

Reference Type BACKGROUND
PMID: 31551419 (View on PubMed)

Mahfouf W, Hosseini M, Muzotte E, Serrano-Sanchez M, Dousset L, Moisan F, Rachidi W, Taieb A, Rudolf J, Rezvani HR. Loss of Epidermal HIF-1alpha Blocks UVB-Induced Tumorigenesis by Affecting DNA Repair Capacity and Oxidative Stress. J Invest Dermatol. 2019 Sep;139(9):2016-2028.e7. doi: 10.1016/j.jid.2019.01.035. Epub 2019 Mar 13.

Reference Type BACKGROUND
PMID: 30878676 (View on PubMed)

Other Identifiers

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CHUBX 2019/3

Identifier Type: -

Identifier Source: org_study_id

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