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Clinical Trials/NCT04389112
NCT04389112
Recruiting
Not Applicable

Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions

University Hospital, Bordeaux1 site in 1 country200 target enrollmentFebruary 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cutaneous Squamous Cell Carcinoma
Sponsor
University Hospital, Bordeaux
Enrollment
200
Locations
1
Primary Endpoint
Proportion of patients who have an oxidative profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS))
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2020
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Every patient with suspected lesion :
  • 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

Outcomes

Primary Outcomes

Proportion of patients who have an oxidative profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS))

Time Frame: Day 1

Metabolic profiling of different stages of carcinogenesis: glycolysis, oxidative phosphorylation

Proportion of patients who have a glycolysis profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS))

Time Frame: Day 1

Metabolic profiling of different stages of carcinogenesis: glycolysis, oxidative phosphorylation

Secondary Outcomes

  • Evaluation of mitochondrial metabolism on skin biopsies(Day 1)
  • Evaluation of skin differentiation markers(Day 1)
  • Evaluation of cSCC aggressiveness markers(Day 1)
  • Evaluation of cancer proliferative features on skin biopsies(Day 1)
  • Evaluation of skin apoptotic markers(Day 1)

Study Sites (1)

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