NCT06476964

Brief Summary

A collection of biological samples (skin) will be created to meet the objectives. Skin biopsies will be taken (excluding on face and fold), in accordance with standard practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress89%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

June 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

July 4, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

June 19, 2024

Last Update Submit

July 4, 2024

Conditions

Skin Cancer

Keywords

Actinic keratosis,Cutaneous squamous cell carcinomamitochondriametabolism

Outcome Measures

Primary Outcomes (2)

  • Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissue

    Evaluation of metabolic changes involved in cSCC progression

    Day 1

  • Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.

    Characterization of the immune cells infiltrate Expression of multiple immune cell markers will be assessed in samples from different subtypes of cSCC by single cell RNA sequencing.

    Day 1

Secondary Outcomes (3)

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

    Day 1

  • percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index

    Day 1

  • percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test)

    Day 1

Study Arms (4)

patients with actinic keratosis(AK)

EXPERIMENTAL
Procedure: skin biopsies

patients with squamous cell carcinoma in situ (in situ cSCC)

EXPERIMENTAL
Procedure: skin biopsies

patients with squamous cell carcinomas infiltrative (infiltrative cSCC)

EXPERIMENTAL
Procedure: skin biopsies

patient with invasive metastases (cSCC with cutaneous metastases)

EXPERIMENTAL
Procedure: skin biopsies

Interventions

skin biopsiesPROCEDURE

Additional punches of 3 mm from a skin lesion part of a skin biopsy performed as part of routine care, an additional (optional) biopsy of healthy skin

patient with invasive metastases (cSCC with cutaneous metastases)patients with actinic keratosis(AK)patients with squamous cell carcinoma in situ (in situ cSCC)patients with squamous cell carcinomas infiltrative (infiltrative cSCC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 or over,
  • Patients with suspected AK, or cSCC lesions (in situ, infiltrating or metastatic),
  • Patients able to sign a consent form,
  • Patients affiliated to a French Social Security system.

You may not qualify if:

  • Patients who have previously received systemic treatment (chemotherapy, immunotherapy),
  • Patients with cSCC or AK localized on visible zone of the face or folds
  • Patients under guardianship or guardianship,
  • Patient not affiliated to a French Social Security system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Bordeaux - Department of Dermatology

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Skin NeoplasmsKeratosis, Actinic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesPrecancerous ConditionsKeratosis

Study Officials

  • Marie BEYLOT-BARRY, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Hamid-Reza REZVANI, PhD

    Bordeaux Institute of Oncology

    STUDY CHAIR

Central Study Contacts

Marie BEYLOT-BARRY, MD, PhD

CONTACT

+335 57 82 25 00marie.beylot-barry@chu-bordeaux.fr

Christine ALFARO

CONTACT

+335 57 82 25 09christine.alfaro@chu-bordeaux.fr

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

June 19, 2024

First Posted

June 27, 2024

Study Start

July 4, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

July 8, 2024

Record last verified: 2024-07

Locations

FR(1)