Improving Early Detection of Melanoma Recurrence With Circulating Tumor DNA (ctDNA)
- Conditions
- Melanoma
- Registration Number
- NCT05736523
- Lead Sponsor
- University of Utah
- Brief 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-surgery
Study 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.
- Detailed Description
The investigators hypothesize that ctDNA levels drawn before and after surgical resection of a primary tumor and either sentinel lymph nodes or clinically involved metastatic lymph nodes will correlate with the presence of sentinel node microscopic metastatic disease and clinically evident nodal metastatic disease. The investigators also predict that approximately 20% of sentinel lymph node negative Stage IIB/IIC patients will have evidence of ctDNA positivity post-surgery.
Primary Objective:
* To assess the feasibility of generating patient specific ctDNA assay from Signatera© test for primary melanoma samples submitted with clinical stage IIB/IIC and stage III melanoma patients.
Secondary Objective(s):
* To investigate serum levels of melanoma ctDNA pre and postoperatively in clinical Stage IIB/C and Stage III melanoma patients.
* To evaluate the relationship of serum ctDNA levels pre-operatively with sentinel lymph node biopsy status in clinical Stage IIB/C patients.
* Evaluate for clearance or persistence of ctDNA levels post complete resection in patients with clinically evident lymph node metastasis (Stage IIIB/C/D).
* Assess feasibility of collection of pre- and post-operative stool samples
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum ctDNA acquisition, processing and results Within 4 weeks pre-surgery through a maximum of 4 weeks post-surgery The proportion of cases in which sample acquisition, processing and return of results from the two initial ctDNA (serum VAF allele levels, ng/ml) analyses occurs within 6 weeks of acquisition of the post-operative serum sample. The two ctDNA analyses are from the initial tumor biopsy and blood, and post-operative blood draw.
- Secondary Outcome Measures
Name Time Method Pre and Post-operative Serum Variant Allele Frequency Within 4 weeks pre-surgery through a maximum of 4 weeks post-surgery Pre-operative and post-operative serum Variant allele frequency (VAF) ng/ml from the Signatera© test in all evaluable patients
Pre and Post-operative Stool Samples Within 4 weeks pre-surgery through a maximum of 4 weeks post-surgery Proportion of cases in which pre-operative and post-operative patient stool samples are successfully obtained
The proportion of patients for which serum VAF levels (ng/ml) are undetectable post complete resection of either sentinel nodes or clinically evident lymph node metastases Within 4 weeks post-surgery The proportion of patients for which serum VAF levels (ng/ml) are undetectable post complete resection of either sentinel nodes or clinically evident lymph node metastases
Pre-operative serum VAF levels (ng/mL) from Signatera© stratified by pre-operative sentinel lymph node and clinically evident lymph node metastatic status. Within 4 weeks post-surgery Evaluate association of pre-operative serum VAF levels (ng/ml) from Signatera© stratified by pre-operative sentinel lymph node eligible (Clinical stage IIB/IIC) patients vs. patients with clinically evident lymph node metastases (clinical stage III).
Quantify the number of patients who develop detectable VAF levels (ng/ml) within the first 3 years after surgery and evaluate possible correlation with recurrence. 3 years post resection of the last patient enrolled. Proportion of participants with detectable VAF levels (ng/ml) using the Signatera© test at any time point during the surveillance period and any clinical or radiologic evidence of recurrence.
Association of pre-operative and post-operative serum Variant allele frequency (VAF) levels (ng/ml) from the Signatera© test and sentinel lymph node biopsy metastatic status Within 4 weeks pre-surgery Evaluate the relationship of serum Variant allele frequency (VAF) levels (ng/ml) pre-operatively with sentinel lymph node biopsy clinical outcome (positive/negative for metastatic disease) in clinical Stage IIB/C melanoma patients undergoing sentinel lymph node biopsy.
Trial Locations
- Locations (2)
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Intermountain Medical Center🇺🇸Murray, Utah, United States