Last updated: March 30, 2022
Sponsor: OncoBeta Therapeutics
Overall Status: Active - Recruiting
Phase
N/A
Condition
Skin Cancer
Treatment
N/AClinical Study ID
NCT05135052
OB-RHSCT-101
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically nodenegative disease
- Confirmed Histology, and with depth of lesion noted
- Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3lesions are not excluded from the study, however 3 target lesions are determined forstudy evaluation only.)
- Subjects able and willing to comply with the requirements of the study
- Age >=18 years
- Informed Consent signed by the subject consenting to undergo the study
- Lesions up to 8cm2
- Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriateclinically by treating clinician
- Subjects who are not deemed suitable for surgery, for example due to tumour location,performance status or other comorbidities as deemed relevant by the treating clinician
- Patients who may have declined Surgery and/or fractionated Radiation Therapy
Exclusion
Exclusion Criteria:
- Inability to personally provide written informed consent or to understand andcollaborate throughout the study
- Inability or unwillingness to comply with study requirements
- Prior treatment with surgery or radiation therapy for their target lesion(s)
- Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment
- Lupus and Scleroderma
- Basal cell naevus syndrome, xeroderma, vitiligo and albinism
- Prior laser at the tumour site
- Malignant melanoma systemic therapy ongoing
- Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry
- A tumour affecting nerves or bony structures
- Clinical concern of metastatic disease
- Pregnancy and/or Lactation
- Pathological exclusions: Perineural Invasion, Lymphovascular invasion
- Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower),Vermillion lip
Study Design
Total Participants: 210
Study Start date:
January 17, 2022
Estimated Completion Date:
May 15, 2024
Connect with a study center
Genesis Care Health Hub at RNS
Sydney, New South Wales 2065
AustraliaActive - Recruiting
John Flynn Hospital
Tugun, Queensland 4224
AustraliaActive - Recruiting
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