Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions (MITOSKIN)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinomas

Treatments: Other: biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04389112

CHUBX 2019/3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Patients with actinic keratoses

Experimental group

Treatment:

Other: biopsy

patients with squamous cell carcinoma in situ

Experimental group

Treatment:

Other: biopsy

patients with squamous cell carcinomas

Experimental group

Treatment:

Other: biopsy

patient with invasive metastates

Experimental group

Treatment:

Other: biopsy