Impact of Preoperative High-Frequency Ultrasound Cutaneous Lesion Extent Assessment on Excision Margin Positivity in Head and Neck Skin Cancer, and the Relationship Between Preoperative Assessment Methods, Inadequate Excision Margins, and Tumor Recurrence (HFUS-CLEAR)

January 15, 2026 updated by: Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

Impact of Preoperative High-Frequency Ultrasound Cutaneous Lesion Extent Assessment on Excision Margin Positivity in Head and Neck Skin Cancer, and the Relationship Between Preoperative Assessment Methods, Inadequate Excision Margins, and Tumor Recurrence (HFUS-CLEAR)

Non-melanoma skin cancers (NMSC), particularly basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), are the most common malignancies in Caucasians, with the majority of tumors located in the head and neck due to chronic ultraviolet exposure. Although BCC has very low metastatic potential, while cSCC carries a higher risk of nodal spread, both can cause significant local tissue destruction and functional and cosmetic impairment. Complete excision with histologically clear margins remains the standard treatment; however, incomplete or close excision margins are reported in a substantial proportion of cases and are associated with increased risk of local recurrence, need for additional treatment, and higher healthcare costs.

Preoperative dermoscopy improves delineation of lateral tumor borders but does not assess depth of invasion. High-frequency ultrasound (HFUS) is a rapid, non-invasive imaging modality that can visualize superficial skin structures and estimate tumor thickness. Previous studies have suggested good agreement between HFUS and histopathologic depth of invasion, but results are not fully consistent, and HFUS has not yet been incorporated into major guideline recommendations for preoperative assessment of NMSC. Further prospective data are needed to clarify whether HFUS can improve surgical planning and margin control.

This prospective study is designed to assess the impact of adding preoperative HFUS to standard dermoscopic evaluation in head and neck BCC and cSCC. The primary objectives are: (1) to compare the frequency of positive or inadequate (<1 mm) histopathologic excision margins between lesions assessed with dermoscopy alone and those assessed with both dermoscopy and HFUS; and (2) to evaluate 5-year local recurrence rates in relation to preoperative assessment method, histopathologic margin status, and subsequent management of inadequate margins (observation, non-surgical treatment, or scar excision). Secondary and additional objectives include: assessing concordance between HFUS-measured and histopathologic depth of invasion; determining the frequency of residual tumor in scars excised after inadequate margins; evaluating recurrence rate according to the site of inadequate margins (lateral vs deep); and identifying patient-related, tumor-related, surgical, and histopathologic predictors of inadequate margins and recurrence. Approximately 400 lesions (BCC or cSCC of the head and neck) qualified for curative surgical excision will be included. Each lesion will constitute an independent study case. All lesions will undergo preoperative assessment, including clinical evaluation with detailed medical history and dermoscopy; in one cohort, lesions will additionally be evaluated with HFUS. HFUS will be performed with an 18-MHz linear probe, using superficial B-mode and color Doppler. Maximum tumor depth will be recorded from the epidermal surface (or granular layer) to the deepest hypoechoic point, with assessment of potential infiltration of deeper structures when visible. Surgical excision and postoperative care will follow standard clinical practice. Postoperative histopathologic assessment of FFPE tumor samples will record tumor histologic type and subtype, margin status, width, depth of invasion, differentiation, inflammation, elastosis, perineural or vascular invasion, and other routinely assessed diagnostic features. In the event of positive or inadequate excision margins, patients will be referred, after consultation with a dermatologist, for further management (observation, non-surgical treatment, or scar excision), depending on clinical indications and patient preferences. Participation in the study will not influence the primary surgical treatment or any decisions regarding subsequent management.

Patients will be followed for at least 5 years according to current clinical guidelines, with dermoscopic skin examination and documentation of local recurrence and its management. The study aims to determine whether incorporating HFUS into preoperative assessment can reduce the frequency of inadequate histologic margins and improve long-term local control in head and neck NMSC.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • National Medical Institute of the Ministry of the Interior and Administration in Warsaw
        • Contact:
        • Principal Investigator:
          • Laura M Ziuzia-Januszewska, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will include all eligible cutaneous basal cell carcinomas (BCC) and cutaneous squamous cell carcinomas (cSCC) of the head and neck surgically treated at the Department of Otolaryngology. Each eligible lesion will constitute an independent study case. In patients with multiple tumors, each lesion may be included separately if it meets all inclusion criteria. Participation requires informed, written consent from the patient after reviewing the Patient Information Sheet.

Description

Inclusion Criteria:

  • Cutaneous lesion located in the head and neck region with a preoperative diagnosis of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), established by dermoscopy or biopsy, and qualified for surgical excision with curative intent.
  • patient age of 18 years or older.
  • Ability of patient to provide voluntary, informed, written consent for participation in the study.
  • Confirmation that the patient has read and understood the Patient Information Sheet.

Exclusion Criteria:

  • Excisional biopsies without radical intent.
  • Lack of histopathologic confirmation of BCC or SCC in the postoperative specimen (incorrect dermoscopic qualification).
  • Inability to perform radical surgical excision due to excessive tumor extent, poor general condition of the patient, or lack of patient consent for surgery.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lesions with tumor extent assessed preoparatively with high-frequency ultrasound and dermoscopy
Diagnostic test: High-Frequency Ultrasound
High-frequency ultrasound examination of the tumor will be performed using a GE LOGIQ S7 Expert system with an L8-18i-D linear probe (18 MHz). Imaging will include superficial-preset B-mode gray-scale assessment and color Doppler evaluation of lesion vascularity. Standard ultrasound gel will be applied; the probe will be positioned perpendicularly to the skin surface without pressure, avoiding direct contact with the tumor. Images and measurements will be obtained in at least two orthogonal planes. Maximum tumor depth will be recorded as the greatest value measured from the epidermal surface (or granular layer, when visible) to the deepest hypoechoic point of the lesion. When possible, infiltration of deeper structures (e.g., subcutaneous fat, salivary glands, muscle) will also be evaluated.
Other Names:
  • HFUS
  • high-frequency ultrasonography
Diagnostic test: Dermoscopy
All lesions will undergo standard preoperative dermoscopic evaluation performed by a consultant dermatologist, including assessment of tumor extent and marking of dermoscopically visible tumor borders.
Other Names:
  • Dermatoscopy
Lesions with tumor extent assessed preoparatively with dermoscopy alone
Diagnostic test: Dermoscopy
All lesions will undergo standard preoperative dermoscopic evaluation performed by a consultant dermatologist, including assessment of tumor extent and marking of dermoscopically visible tumor borders.
Other Names:
  • Dermatoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excision Margin Status
Time Frame: Postoperative pathology results (within 30 days after excision)
Assessment of the frequency of positive or inadequate (defined as positive or <1 mm) histopathologic excision margins in head and neck skin cancer specimens, comparing tumors evaluated preoperatively with dermoscopy alone versus dermoscopy plus high-frequency ultrasound (18 MHz). Margin status will be extracted from postoperative pathology reports.
Postoperative pathology results (within 30 days after excision)
Five-Year Tumor Recurrence
Time Frame: Up to 5 years after primary tumor excision
Evaluation of recurrence rates over 5 years based on the preoperative tumor assessment approach (dermoscopy vs. dermoscopy plus HFUS), histopathologic margin status (complete vs. incomplete), and the clinical management chosen in cases of incomplete margins (observation, non-surgical therapies, or scar excision).
Up to 5 years after primary tumor excision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance Between HFUS-Measured and Histopathologic Depth of Invasion
Time Frame: Preoperative HFUS assessment and postoperative histopathology (within 30 days)
Quantitative assessment of concordance coefficient between tumor depth measured preoperatively using high-frequency ultrasound (18 MHz) and depth of invasion reported in postoperative histopathology.
Preoperative HFUS assessment and postoperative histopathology (within 30 days)
Recurrence Rates According to Site of Incomplete Histopathologic Margins
Time Frame: Up to 5 years after primary tumor excision
Assessment of whether tumor recurrence rates differ depending on the site of incomplete histopathologic margins recorded in the primary excision - peripheral(lateral) margins vs. deep margin.
Up to 5 years after primary tumor excision
Frequency of Residual Tumor Cells in Scar Excision Following Incomplete Margins
Time Frame: Scar excision histopathology (within 90 days after primary excision)
Determination of the proportion of histopathologic evidence of residual tumor cells in scar tissue removed after incomplete excision margins, based on pathology evaluation of the re-excision specimen.
Scar excision histopathology (within 90 days after primary excision)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Related and Tumor-Related Risk Factors for Incomplete Margins
Time Frame: Postoperative pathology results (within 30 days after excision)
Evaluation of potential predictors of incomplete histopathologic margins, including demographic and clinical patient characteristics, comorbidities and medical history (such as immunosuppression, prior organ transplant, prior head and neck radiotherapy, previous skin malignancies and premalignant lesions), tumor growth rate, preoperative clinical tumor features (size, location, poorly defined borders, ulceration, primary vs recurrent lesion), surgical technique and surgical excision margin (assessed macroscopically), and histopathologic features (histologic subtype, depth of invasion, differentiation grade, inflammation, and elastosis). Logistic regression models will be applied.
Postoperative pathology results (within 30 days after excision)
Patient-Related and Tumor-Related Risk Factors for Tumor Recurrence
Time Frame: Up to 5 years after primary tumor excision
Evaluation of potential factors associated with 5-year recurrence, including demographic and clinical patient characteristics, comorbidities and medical history (such as immunosuppression, prior organ transplant, prior head and neck radiotherapy, previous skin malignancies and premalignant lesions), tumor growth rate, preoperative clinical tumor features (size, location, poorly defined borders, ulceration, primary vs recurrent lesion), surgical technique and surgical excision margin (assessed macroscopically), and histopathologic features (histologic subtype, depth of invasion, differentiation grade, inflammation, and elastosis). Logistic regression models will be applied.
Up to 5 years after primary tumor excision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 23, 2025

Primary Completion (Estimated)

November 30, 2033

Study Completion (Estimated)

November 30, 2033

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/BW/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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