Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions
MITOSKIN
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2020
CompletedFirst Submitted
Initial submission to the registry
March 31, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedNovember 23, 2022
November 1, 2022
2.8 years
March 31, 2020
November 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patients who have a glycolysis profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS))
Metabolic profiling of different stages of carcinogenesis: glycolysis, oxidative phosphorylation
Day 1
Proportion of patients who have an oxidative profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS))
Metabolic profiling of different stages of carcinogenesis: glycolysis, oxidative phosphorylation
Day 1
Secondary Outcomes (5)
Evaluation of skin differentiation markers
Day 1
Evaluation of cSCC aggressiveness markers
Day 1
Evaluation of skin apoptotic markers
Day 1
Evaluation of mitochondrial metabolism on skin biopsies
Day 1
Evaluation of cancer proliferative features on skin biopsies
Day 1
Study Arms (4)
Patients with actinic keratoses
EXPERIMENTALpatients with squamous cell carcinoma in situ
EXPERIMENTALpatients with squamous cell carcinomas
EXPERIMENTALpatient with invasive metastates
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior systemic treatment such as checkpoint inhibitors or chemotherapy.
- Patients with cSCC or AK localized on visible zone of the face or folds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Saint-André - CHU de Bordeaux
Bordeaux, 33000, France
Related Publications (4)
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.
PMID: 25542180BACKGROUNDHosseini 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.
PMID: 29925003BACKGROUNDHosseini 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.
PMID: 31551419BACKGROUNDMahfouf 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.
PMID: 30878676BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie BEYLOT-BARRY, MD, PhD
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2020
First Posted
May 15, 2020
Study Start
February 28, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
November 23, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share