Validation of Clinical Biomarkers Using Spatial Transcriptomics and Development of a Diagnostic Test to Characterize the Progression Potential of Cutaneous Precancerous Lesions (DIAGNO-KA)

May 29, 2026 updated by: Centre Hospitalier Régional Metz-Thionville
Actinic keratoses are precancerous skin lesions that are the most common among all cancers and precancerous conditions in fair-skinned populations. The distinctive feature of these actinic keratoses is that some progress into skin cancers known as cutaneous carcinomas, while others regress spontaneously; currently, there is no way to distinguish between them, either through clinical observation or biological methods. The goal of the Diagno-KA project is to develop a diagnostic test that would distinguish between actinic keratoses that progress to cancer-so they can be surgically removed early (before they become severe and metastasize)-and those that regress, thereby avoiding unnecessary surgical intervention (to prevent scarring).

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Metz, France
        • CHR Metz-Thionville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with skin carcinomas and actinic keratoses

Description

Inclusion Criteria:

  • patients with skin carcinomas and actinic keratoses

Exclusion Criteria:

  • minor patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biomarker validation
Time Frame: Until the end of the study on average 2 years
Until the end of the study on average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-01-Obs-CHRMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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