Skin CancerDIAGNO-KANCT07624981
Validation of Clinical Biomarkers Using Spatial Transcriptomics and Development of a Diagnostic Test to Characterize the Progression Potential of Cutaneous Precancerous Lesions
An observational study of Skin Cancer and Diagnostic, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Diagnostic
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: patients with skin carcinomas and actinic keratoses
Who may be able to join
- patients with skin carcinomas and actinic keratoses
Who cannot join
- minor patient
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Skin Cancer, Diagnostic
- Medical subject headings
- Skin Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker validation
Measured: Until the end of the study on average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Feb 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624981
- Sponsor's protocol ID
- 2026-01-Obs-CHRMT
- Acronym
- DIAGNO-KA
- Status last verified
- Apr 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinical Biomarkers Using Spatial Transcriptomics and Development of a Diagnostic Test to Characterize the Progression Potential of Cutaneous Precancerous Lesions
- ClinicalTrials.gov ID
- NCT07624981
- Acronym / sponsor ID
- DIAGNO-KA / 2026-01-Obs-CHRMT
- Conditions
- Skin Cancer, Diagnostic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with skin carcinomas and actinic keratoses
Key inclusion criteria (1 listed)
- patients with skin carcinomas and actinic keratoses
Key exclusion criteria (1 listed)
- minor patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarker validation
Time frame: Until the end of the study on average 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Diagnostic, run by Centre Hospitalier Régional Metz-Thionville 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
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?
Biomarker validation (time frame: Until the end of the study on average 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.