Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT02939027
Eligibility Criteria:
Inclusion Criteria:
* Men or women ≥18 years old.
* Estimated life expectancy of ≥5 years
* Histopathologic diagnosis of early and primary Basal Cell Carcinoma (BCC)
* Clinical stage of BCC: T1 or T2 (by AJCC 2010 criteria, see Table 1)
* Histological subtypes: Superficial BCC or nodular BCC
* Maximum diameter of lesion: 20 mm
* Maximum depth of invasion: 4 mm.
* Ability to provide informed consent
* Punch biopsy of primary tumor to depth of reticular dermis
Exclusion Criteria:
* Men or women \<18 years old.
* Estimated life expectancy \<5 years.
* BCC that was previously treated (ie, recurrent BCC)
* BCC in region adjacent to or overlapping with region of prior radiotherapy
* BCC on irregular surface (ie, target area not flat)
* BCC adjacent to or overlapping with burn or scar
* BCC in area prone to trauma
* BCC in area with compromised lymphatic drainage or vascular supply
* Inflammatory process in target area
* Pregnancy or lactation
* Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
* Diabetes that is poorly controlled (Hg A1c \>7%)
* Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
* Receipt of treatment with another investigational device or drug
* Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
* Receipt or plan to receive chemotherapy within 6 weeks of radiation therapy
* High likelihood of protocol non-compliance (in opinion of investigator)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02939027
Study Brief:
Protocol Section:
NCT02939027