Predicting the Risk of Recurrence Disease in Cutaneous Squamous Cell Carcinoma
A
Ally-Khan Somani, MD
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
N/A
5 participants needed
1 Location
Brief description of study
Castle Biosciences Inc. (CBI), has developed an test that evaluates the biological nature of an individual patient’s tumor by using gene expression profiling to classify it as a low- or high-risk tumor. With this information, it is hoped a doctor and patient together, can make important decisions about treatment planning. This study is being done to further confirm the accuracy of this test in predicting the risk a tumor will come back or spread to another part of the body.
Detailed description of study
.This study will collect information and a sample of a skin cancer tumor that was previously removed for testing. During the 3 years of follow-up period, any new primary invasive cSCC lesions diagnosed between diagnosis of the tumor under study and consent/enrollment as well as those that occur during study participation may also be sent for testing to the sponsor, Castle Biosciences Inc.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: cutaneous squamous cell carcinoma
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
- Patient with pathologically confirmed invasive cSCC diagnosed after January 1, 2017 and is under active follow-up.
- Patient who has formalin fixed paraffin embedded (FFPE) tissue available from their primary tumor biopsy or wide local excision
- Patient has a primary invasive cSCC tumor. Additional criteria apply regarding tumor.
- OR the patient must meet one of the following criteria: Is immunocompromised due to solid organ transplant, Lymphoma/Leukemia or HIV; Is experiencing neurological symptoms in the area of the tumor
- Patient is able to provide informed consent.
- Patient with more than one invasive cSCC must have all prior invasive cSCC tumors within 3 years, available for testing.
- Patient is likely to follow up with treating physician.
Exclusion Criteria:
- Patient who is immunosuppressed for any reason other than solid organ transplant, Lymphoma / Leukemia or HIV.
- Patient not reasonably expected to live at least 3 years in the absence of the cSCC.
- Patient who has been or is being treated with BRAF inhibitors
- Patient with a diagnosis of any type of invasive malignancy, with the exception of Leukemia, lymphoma, non-metastatic breast cancer and non-metastatic prostate cancer both with treatment completed more than 5 years prior to diagnosis of cSCC.
- Additionally, Cutaneous Basal Cell Carcinoma or Melanoma in situ considered by the investigator to be cured is allowed.
- Other malignancies may be considered on a case by case basis but must be approved by the medical monitor prior to enrollment.
- Patient whose primary tumor is not considered invasive (e.g. Bowens disease) or definitively cSCC [e.g. Keratoacanthoma (note: SCC KA-type is acceptable)].
- Patient unable to provide informed consent.
- Staff and family members of Investigator.
- Patients previously enrolled in the prior Castle Biosciences Inc.
Updated on
01 Aug 2024.
Study ID: 10195, DERM-CBI-2019-CSCC-PVS-001
