Improving Early Detection of Melanoma Recurrence With Circulating Tumor DNA (ctDNA)

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.

Sex

All

Minimum age

18 Years

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:

  1. 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.

     OR
  2. For 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 resection
* Patient 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

• BACKGROUNDGershenwald JE, Scolyer RA, Hess KR, Sondak VK, Long GV, Ross MI, Lazar AJ, Faries MB, Kirkwood JM, McArthur GA, Haydu LE, Eggermont AMM, Flaherty KT, Balch CM, Thompson JF; for members of the American Joint Committee on Cancer Melanoma Expert Panel and the International Melanoma Database and Discovery Platform. Melanoma staging: Evidence-based changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017 Nov;67(6):472-492. doi: 10.3322/caac.21409. Epub 2017 Oct 13. PMID 29028110
• BACKGROUNDEggermont AMM, Blank CU, Mandala M, Long GV, Atkinson V, Dalle S, Haydon A, Lichinitser M, Khattak A, Carlino MS, Sandhu S, Larkin J, Puig S, Ascierto PA, Rutkowski P, Schadendorf D, Koornstra R, Hernandez-Aya L, Maio M, van den Eertwegh AJM, Grob JJ, Gutzmer R, Jamal R, Lorigan P, Ibrahim N, Marreaud S, van Akkooi ACJ, Suciu S, Robert C. Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma. N Engl J Med. 2018 May 10;378(19):1789-1801. doi: 10.1056/NEJMoa1802357. Epub 2018 Apr 15. PMID 29658430
• BACKGROUNDLong GV, Hauschild A, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma. N Engl J Med. 2017 Nov 9;377(19):1813-1823. doi: 10.1056/NEJMoa1708539. Epub 2017 Sep 10. PMID 28891408
• BACKGROUNDWeber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10. PMID 28891423
• BACKGROUNDChristensen E, Birkenkamp-Demtroder K, Sethi H, Shchegrova S, Salari R, Nordentoft I, Wu HT, Knudsen M, Lamy P, Lindskrog SV, Taber A, Balcioglu M, Vang S, Assaf Z, Sharma S, Tin AS, Srinivasan R, Hafez D, Reinert T, Navarro S, Olson A, Ram R, Dashner S, Rabinowitz M, Billings P, Sigurjonsson S, Andersen CL, Swenerton R, Aleshin A, Zimmermann B, Agerbaek M, Lin CJ, Jensen JB, Dyrskjot L. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019 Jun 20;37(18):1547-1557. doi: 10.1200/JCO.18.02052. Epub 2019 May 6.