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Active Not Recruiting
NCT05736523
Improving Early Detection of Melanoma Recurrence With Circulating Tumor DNA (ctDNA)
Conditions: Melanoma
Sex: All
Ages: 18 Years – N/A
Enrollment: 28
Sponsor: University of Utah
Location: United States
Summary
This is a non-randomized experimental biomarker study evaluating ctDNA levels in patients with stage IIB/C and stage IIIB/C/D melanoma skin cancer pre and post-surgeryStudy participants will complete a ctDNA test within 4 weeks of their planned surgical resection of their melanoma.
Within 4 weeks post-surgery another ctDNA test will be completed.
During these time points stool samples and diet questionnaires will be collected for biospecimen banking.
Eligibility Criteria
INCLUSION CRITERIA:Patient must be ≥ 18 years of age.Patient must be a surgical candidate with Stage IIB, IIC melanoma or fully resectable Stage III B/C/D cutaneous melanoma.Patients with resectable in transit/nodal metastatic disease who have had prior adjuvant or systemic/intralesional therapy can be included provided that the planned resected lesions either progressed or developed while on or after completion of prior treatment.
Patients with resectable in transit/nodal metastatic disease who are treated with neoadjuvant therapy prior to resection are also eligible provided that the initial blood and tumor biopsy sample are taken prior to initiation of neoadjuvant therapy.Tissue available meeting one of the following criteria:For patients with Clinical stage II primary tumors that have been biopsied prior to evaluation by the surgeon, or those with stage III tumors that have been partially/fully excised prior to definitive surgery, adequate tissue will be confirmed prior to enrollment to follow Natera's tissue sample collection instructions when selecting the appropriate specimen.ORFor patients with bulky lymph nodes involved with clinically evident, biopsy proven metastatic disease, in transit metastasis, or with extensive residual primary tumor present prior to excision, and in the treating surgeon's assessment there will be extensive tumor for evaluation, the patient can be enrolled with tissue adequacy evaluation post resectionPatient is willing to provide blood samples for Signatera testing as outlined in the study calendar.Patient is able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.EXCLUSION CRITERIA:Patient is unable to provide informed consent or is unwilling to sign an approved consent form.Patient has other clinically significant disorders that would preclude safe study participation
Source: ClinicalTrials.gov (NCT05736523). StuddyBuddy aggregates publicly available trial information.