Added value of OCT for diagnosing recurrent BCC after non-invasive treatment

Added value of OCT for diagnosing recurrent BCC after non-invasive treatment - OCT for diagnosing recurrent BCC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55343

Enrollment

100

Registered

2020-10-02

Start date

2021-01-15

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Basal cell carcinoma skin cancer

Interventions

Optical Coherence Tomography

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients (>18 years) Received non-invasive treatment for superficial BCC Clinical follow-up within 5 years post-treatment

Exclusion criteria

Exclusion criteria: Patients unable to sign informed consent

Design outcomes

Primary

Measure	Time frame
To investigate the added value of OCT as a non-invasive tool for the diagnosis of recurrent BCC, in follow-up of patients who underwent topical therapy of superficial BCC. We will examine whether addition of OCT to clinical and dermoscopic examination leads to increased detection of recurrent BCCs, possibly at an earlier stage. The added diagnostic value of OCT, when compared with clinical and dermoscopic examination, will be evaluated using the results of punch biopsy as reference standard. Diagnostic parameters, such as sensitivity, specificity, positive and negative predictive value and area under the curve (AUC) under the receiver operating characteristic (ROC) curve with 95% confidence intervals will be calculated.*	—

Measure

Time frame

To investigate the added value of OCT as a non-invasive tool for the diagnosis of recurrent BCC, in follow-up of patients who underwent topical therapy of superficial BCC. We will examine whether addition of OCT to clinical and dermoscopic examination leads to increased detection of recurrent BCCs, possibly at an earlier stage. The added diagnostic value of OCT, when compared with clinical and dermoscopic examination, will be evaluated using the results of punch biopsy as reference standard. Diagnostic parameters, such as sensitivity, specificity, positive and negative predictive value and area under the curve (AUC) under the receiver operating characteristic (ROC) curve with 95% confidence intervals will be calculated.*

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Secondary

Measure	Time frame
To perform a subanalysis in order to specify the added value of OCT per treatment method (imiquimod, 5-fluorouracil and PDT). To perform an inter-observer analysis between investigators with different levels of OCT experience. To investigate the number of unnecessary punch biopsies due to incorrect OCT diagnosis. To investigate the ability of OCT to correctly predict BCC subtype. Correct prediction of BCC subtype with OCT is relevant, since recurrent superficial BCC may be treated with another round of imiquimod cream, whereas as nodular and infiltrative BCCs are treated surgically.	—

Measure

Time frame

To perform a subanalysis in order to specify the added value of OCT per treatment method (imiquimod, 5-fluorouracil and PDT). To perform an inter-observer analysis between investigators with different levels of OCT experience. To investigate the number of unnecessary punch biopsies due to incorrect OCT diagnosis. To investigate the ability of OCT to correctly predict BCC subtype. Correct prediction of BCC subtype with OCT is relevant, since recurrent superficial BCC may be treated with another round of imiquimod cream, whereas as nodular and infiltrative BCCs are treated surgically.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)