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Construction and Validation of a Multi-dimensional Data Model for Predicting the Efficacy of Photodynamic Therapy in Non-Melanoma Skin Tumors and Cutaneous Precancerous Lesions

Construction and Validation of a Multi-dimensional Data Model for Predicting the Efficacy of Photodynamic Therapy in Non-Melanoma Skin Tumors and Cutaneous Precancerous Lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119240
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-25
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis, Bowen's disease/ cutaneous squamous cell carcinoma in situ, Basal Cell Carcinoma

Interventions

Bowen's disease/ cutaneous squamous cell carcinoma in situ:None
Actinic Keratosis:None
Basal Cell Carcinoma:None

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Retrospective cohort study: a) Patients who were histopathologically diagnosed with AK, cSCCis/BD, or BCC in our hospital between January 2018 and December 2025 and underwent ALA-PDT treatment; b) Age >= 18 years; c) Possess complete clinical information before PDT treatment, pathological reports, and follow-up records for at least 12 months (including efficacy assessments at 3 months and 12 months after treatment). Prospective cohort study: a) Aged >= 18 years, of either gender; b) Clinically and histopathologically confirmed AK, BD, or BCC; c) After clinical evaluation, the lesion is suitable and the patient voluntarily chooses to accept ALA-PDT as the main treatment regimen after being informed; d) Prior to treatment, agree to undergo all examinations specified in the study, including clinical information collection, dermoscopy, and photodynamic fluorescence diagnosis; e) Able to understand the research content, voluntarily sign a written informed consent form, and follow medical advice to complete a follow-up period of at least 12 months;

Exclusion criteria

Exclusion criteria: Retrospective cohort study: a) Lack of clear pathological diagnosis; b) Subjects who received other treatments (such as topical medications, cryotherapy, surgery, etc.) that may affect the efficacy of PDT within 6 months prior to PDT treatment; c) Missing key clinical or follow-up data; Prospective cohort study: a) Patients with known or suspected porphyria, or those allergic to 5-ALA, its metabolites, or excipients; b) Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; c) Received any other treatment for NMSC or precancerous lesions within 6 months; d) Subjects with severe systemic diseases of the heart, liver, kidney, or mental illnesses, who are deemed unsuitable for enrollment by the researchers; e) Participation in other clinical trials that may interfere with the results of this study;

Design outcomes

Primary

MeasureTime frame
Initial Complete Clearance Rate;

Secondary

MeasureTime frame
Sustained Complete Clearance Rate;

Countries

China

Contacts

Public ContactShu Jun Chen

Huashan Hospital, Fudan University

cshujun@fudan.edu.cn+86 21 5288 9999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026