Clinical trial · Interventional
Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery
Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial Basal Cell Carcinomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial studies the effectiveness of narrow margins in patients with low-risk basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the area of normal tissue around a tumor taken out during surgery to make sure all of the cancer is removed. This clinical trial studies tissue samples to determine the least amount of tissue that must be removed to give an acceptable cure rate. This may allow less normal tissue to be removed from patients and may be a less expensive surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Basal Cell Carcinoma | Skin Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (surgical excision)
- description
- Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.
- interventionNames
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (2)
- measure
- Success rate for 1 mm margins
- timeFrame
- Up to 3 years
- description
- The success rate for 1 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion.
- measure
- Success rate for 2 mm margins
- timeFrame
- Up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Location 1. Area M (cheeks, forehead, scalp \& neck) tumor size \< 10 mm 2. Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear) tumor size \< 6 mm 2. Well-defined borders 3. Primary BCC 4. Patient is not immunosuppressed 5. There has not been prior radiotherapy to the site 6. Nodular subtype 7. No perineural involvement-(no neurological deficits grossly) - Exclusion Criteria: 1. Location 1. Area M tumor size \> or = to 10 mm 2. Area H tumor size \> or = to 6 mm 2. Poorly defined borders 3. Recurrent BCC 4. Patient is immunosuppressed 5. There has been prior radiotherapy to the site -
References
Publications (0)
Data not yet available