Skin Tumor Biomarkers by Mass Spectrometry Imaging

NCT06227416 | Unknown

• 1 other identifier: H-20009236
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the ability of mass spectrometry imaging to locate aggregates of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) ex-vivo, and to distinguish areas containing these carcinomas from normal skin. It is suggested that non-melanoma skin cancer (NMSC) cells show a different profile of endogenous lipids than healthe skin tissue which can be used as identifying biomarkers. If that hypothesis is correct it will be possible in the future to develop real-time tissue diagnosis and treatment of NMSC using mass spectrometry guided surgery. Method between 60 and 100 patients with BCCs, SCCs, and actinic keratoses (AK) will be recruited. For patients referred for Mohs surgical procedure at the Department of Dermatology, Bispebjerg Hospital, to treat BCCs or SCCs, three skin sections (5-10 um thick) of the tissue that is already removed will be use in our study. One section will be HE stained so we know exactly where the regions of interest are. Two sections will be used for MS analysis (MSI spectrum and REIMS spectrum). When patients are referred for a procedure to have treated several actinic keratoses (grade 1, 2 or 3) at Department of Dermatology, Bispebjerg Hospital we will take an extra punch biopsy (2-4 mm) depending on the size of the lesion. The biopsy is embedded and sectioned. We will use 3 skin sections (5-10 um thick) we will again use one section for HE staining and two for MS analysis. Multivariate statistical analysis will be performed on all mass spectra using Matlab or similar program. Linear discriminant analysis will be used to identify spectral differences between pre-malignant, cancer and normal tissue. Classification performance will be recorded with a leave-one- patient- out cross- validation scheme.

Conditions

Skin Cancer; Squamous Cell Carcinoma; Basal Cell Carcinoma; Non-melanoma Skin Cancer

Keywords

mass spectrometry imaging; REIMS; MSI; Squamous Cell Carcinoma; Basal Cell Carcinoma; Non-melanoma Skin Cancer; Biomarkers

Outcome Measures

Primary Outcomes (2)

• creation of a diagnostic model capable of identifiying SCC and BCC areas in removed skin sections from BCC and SCC Mohs surgery.

  Establishment of model for detection and identification of basal cell carcinoma tissue and squamous cell carcinoma from healthy tissue by multivariate statistical analysis of lipid biomarkers detected with mass spectrometry imaging. The findings of the method will be compared to pathological designation of cancerous tissue to evaluate the applicability of the model

  after evaluation of samples form at least 180 patients, estimated 4-5 years

• creation of a diagnostic model capable of identifiying areas with actinic keratoses in sections from biopsies with actinic keratoses (pre-malignant lesions).

  Establishment of model for detection and identification of actinic keratoses from healthy tissue by multivariate statistical analysis of lipid biomarkers detected with mass spectrometry imaging. The findings of the method will be compared to pathological designation of cancerous tissue to evaluate the applicability of the model.

  after evaluation of samples form at least 180 patients, estimated 4-5 years

Study Arms (2)

Ex-vivo samples from already excised SCC and BCC areas from mohs surgery

NO INTERVENTION

Ex-vivo samples from punch biopsy from patients with AKs

EXPERIMENTAL

Other: Biopsy

Interventions

Biopsy OTHER

punch biopsy (2-4 mm) depending on the size of the AK lesion.

Ex-vivo samples from punch biopsy from patients with AKs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 18 years of age.
• Patients presenting with AKs, SCCs and BCCs.
• Written informed consent obtained from patient.

You may not qualify if:

• Immunosuppressed patients

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Bispebjerg Hospital Department of Dermatology

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Squamous Cell; Carcinoma, Basal Cell

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Pharm, PhD

Model Details: one group of patients undergoing mohs surgery from which ex-vivo cryosections will be used for the study. one group of patients with actinic keratoses which will have taken a punch biopsy from which ex-vivo cryosections will be included in the study.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 26, 2024
• Study Start: June 15, 2020
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)