AzTrials
AzTrials

Cutaneous Squamous Cell CarcinomaMITOSKINNCT04389112

Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions

A study testing biopsy in people with Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinomas, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteFrance
Study dates
28 Feb 2020to 27 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Every patient with suspected lesion :
  • AK,
  • in situ cSCC,
  • infiltrative cSSC
  • cSCC with recurrent disease
  • cSCC with cutaneous metastases.
Show all 10Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Saint-André - CHU de Bordeaux

    Bordeaux, 33000

Other trials in France

About this study

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.

Read the 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.

Being tested
biopsy
Keywords
Actinic keratosis, mitochondria, metabolism
Medical subject headings
Carcinoma, Basal Cell, Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biopsyOther

    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.

Study groups in NCT04389112
Study groupRoleWhat they receive
Patients with actinic keratosesExperimentalNot described
Receives: Other: biopsy
patients with squamous cell carcinoma in situExperimentalNot described
Receives: Other: biopsy
patients with squamous cell carcinomasExperimentalNot described
Receives: Other: biopsy
patient with invasive metastatesExperimentalNot described
Receives: Other: biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. 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

    Measured: Day 1

Secondary outcomes (5)

  1. Evaluation of skin differentiation markers

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

    Measured: Day 1

  2. Evaluation of cSCC aggressiveness markers

    % 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.

    Measured: Day 1

  3. Evaluation of skin apoptotic markers

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

    Measured: Day 1

  4. Evaluation of mitochondrial metabolism on skin biopsies

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

    Measured: Day 1

  5. Evaluation of cancer proliferative features on skin biopsies

    % 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).

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start28 Feb 2020
  3. Primary completion13 Dec 2022
  4. Study completion27 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04389112
Sponsor's protocol ID
CHUBX 2019/31
Other IDs
2019-A02324-53, 2023-A00894-41
Acronym
MITOSKIN
Status last verified
Nov 2022
First submitted
31 Mar 2020
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25542180

  • 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.

    PubMed 29925003

  • 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.

    PubMed 31551419

  • 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.

    PubMed 30878676

  • Dousset L, Khalife F, Chalopin-Fillot D, Dartigues B, Naji F, Mahfouf W, Muzotte E, Rousseau B, Amoedo N, Claverol S, Bondaz M, Beltzung F, Jullie ML, Vergier B, Taieb A, Favot-Laforge L, Rossignol R, Beylot-Barry M, Nikolski M, Rezvani HR. Metabolism-based scoring of cutaneous squamous cell carcinoma to predict tumour features and responses to treatment with dihydroorotate dehydrogenase inhibitors. Br J Dermatol. 2025 Oct 17;193(5):936-947. doi: 10.1093/bjd/ljaf253.

    PubMed 40577595

Questions about this trial

What is this clinical trial studying?

A study testing biopsy in people with Cutaneous Squamous Cell Carcinoma and Basal Cell Carcinomas, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who have a glycolysis profile (proteomic analysis liquid chromatography-mass spectrometry (LC-MS/MS)) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04389112, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in