NCT06598137

Brief Summary

Using ex-vivo confocal laser scanning microscopy, a reliable statement can be made about the extent, histological structure and possible significance of a skin change without having to send tissue samples for demanding and lengthy histological examinations.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
645

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress46%
Feb 2024Dec 2028

Study Start

First participant enrolled

February 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

3.9 years

First QC Date

September 11, 2024

Last Update Submit

September 23, 2024

Conditions

Benign Skin TumorBasal Cell CarcinomaMelanomaSquamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Reaching the planned number of patients >640

    Reaching the planned number of patients \>640

    approx. 1-4 years

Interventions

Ex vivo confocal laser microscopyPROCEDURE

Using ex-vivo confocal laser scanning microscopy, a reliable statement can be made about the extent, histological structure and possible significance of a skin change without having to send tissue samples for demanding and lengthy histological examinations.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with benign and malignant skin tumors

You may qualify if:

  • Patients with benign and malignant skin tumors

You may not qualify if:

  • Patients unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Dermatology and Allergy LMU Munich

Munich, Bavaria, 80337, Germany

Location

MeSH Terms

Conditions

Carcinoma, Basal CellMelanomaNeoplasms, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)