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Completed

NCT Number: NCT04389112

Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions

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.

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma Basal Cell Carcinomas Carcinoma Carcinoma, Basal Cell Keratosis Keratosis, Actinic Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-André - CHU de Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Evaluation of skin differentiation markers

    Time frame: Day 1

    % of samples in each category (AK, in situ, ...) that present differentiation features are assessed by immunostaining of loricrin, filaggrin, K10

  2. Evaluation of cSCC aggressiveness markers

    Time frame: Day 1

    % of samples expressing aggressive markers will be assessed by evaluating the proliferation index, degree of differentiation, invasion beyond subcutaneous fat, perineural invasion, vascular invasion level of infiltration following immunohistochemistry analyses on formalin-fixed paraffin-embedded tissue sections.

  3. Evaluation of skin apoptotic markers

    Time frame: Day 1

    % of samples with high apoptotic cell death level will be assessed by immunostaining using antibody against cleaved caspase-3.

  4. Evaluation of mitochondrial metabolism on skin biopsies

    Time frame: Day 1

    % of samples with high mitochondrial activity will be evaluated by comparing oxygen consumption rate by different fresh samples.

  5. Evaluation of cancer proliferative features on skin biopsies

    Time frame: Day 1

    % of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test) and cell cycle progression (flow cytometer, western).

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

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

Registry information

Acronym: MITOSKIN

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
May 15, 2020
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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