Gene Expression Profiles and ctDNA for Risk Stratification in Patients With Melanoma

NCT06566404 | Not Yet Recruiting

• 1 other identifier: L2-095
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims at assessing the role of MerlinTM and ctDNA in predicting the nodal status in patients with \>pT3b melanoma, therefore candidate for adjuvant therapy regardless of sentinel lymph node status.

Conditions

Melanoma

Keywords

Melanoma; MerlinTM; ctDNA; sentinel lymph node status

Outcome Measures

Primary Outcomes (1)

• Model Performance

  to compare the performance of the clinicopathologic model and the clinicopathologic model including ctDNA and MerlinTM in predicting SLNB-positivity in terms of area under receiver operating characteristic curve (AUC)

  36 months

Secondary Outcomes (2)

• the estimation of the correlation between ctDNA-positivity and SLNB-positivity

  36 months

• The estimation of the correlation between MerlinTM/ctDNA-positivity and SLNB-positivity

  36 months

Other Outcomes (3)

• The threshold of ctDNA Variant Allele Frequency (VAF)

  36 months

• The estimation of the correlation between ctDNA-positivity and SLNB-positivity

  36 months

• The estimation of the correlation between features

  36 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CORRESPOND is a prospective, longitudinal, observational, non-interventional, translational clinical study enrolling patients with non-metastatic node-negative melanoma.

You may qualify if:

• male or female, aged at least 18 years;
• histologically documented melanoma;
• thickness \> 2 mm (\>pT3b);
• clinical node-negative (cN0) and non-metastatic (cM0) disease at ultrasound (US) and computed tomography (CT) or positron emission tomography (PET) scan;
• known BRAF, N-ras proto-oncogene (NRAS) and tyrosine-protein kinase (c-KIT) mutational status;
• candidate to SLNB;
• consent for the provision of plasma samples for ctDNA analysis and tissue samples (at a central laboratory).

You may not qualify if:

• SLNB performed;
• receipt of neoadjuvant therapy.

Sponsors & Collaborators

• European Institute of Oncology: lead

Related Publications (7)

• Long GV, Swetter SM, Menzies AM, Gershenwald JE, Scolyer RA. Cutaneous melanoma. Lancet. 2023 Aug 5;402(10400):485-502. doi: 10.1016/S0140-6736(23)00821-8. Epub 2023 Jul 24.

  PMID: 37499671 BACKGROUND

• Gentilini OD, Botteri E, Sangalli C, Galimberti V, Porpiglia M, Agresti R, Luini A, Viale G, Cassano E, Peradze N, Toesca A, Massari G, Sacchini V, Munzone E, Leonardi MC, Cattadori F, Di Micco R, Esposito E, Sgarella A, Cattaneo S, Busani M, Dessena M, Bianchi A, Cretella E, Ripoll Orts F, Mueller M, Tinterri C, Chahuan Manzur BJ, Benedetto C, Veronesi P; SOUND Trial Group. Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1557-1564. doi: 10.1001/jamaoncol.2023.3759.

  PMID: 37733364 BACKGROUND

• Eroglu Z, Krinshpun S, Kalashnikova E, Sudhaman S, Ozturk Topcu T, Nichols M, Martin J, Bui KM, Palsuledesai CC, Malhotra M, Olshan P, Markowitz J, Khushalani NI, Tarhini AA, Messina JL, Aleshin A. Circulating tumor DNA-based molecular residual disease detection for treatment monitoring in advanced melanoma patients. Cancer. 2023 Jun 1;129(11):1723-1734. doi: 10.1002/cncr.34716. Epub 2023 Mar 4.

  PMID: 36869646 BACKGROUND

• Bellomo D, Arias-Mejias SM, Ramana C, Heim JB, Quattrocchi E, Sominidi-Damodaran S, Bridges AG, Lehman JS, Hieken TJ, Jakub JW, Pittelkow MR, DiCaudo DJ, Pockaj BA, Sluzevich JC, Cappel MA, Bagaria SP, Perniciaro C, Tjien-Fooh FJ, van Vliet MH, Dwarkasing J, Meves A. Model Combining Tumor Molecular and Clinicopathologic Risk Factors Predicts Sentinel Lymph Node Metastasis in Primary Cutaneous Melanoma. JCO Precis Oncol. 2020;4:319-334. doi: 10.1200/po.19.00206. Epub 2020 Apr 14.

  PMID: 32405608 BACKGROUND

• Mulder EEAP, Dwarkasing JT, Tempel D, van der Spek A, Bosman L, Verver D, Mooyaart AL, van der Veldt AAM, Verhoef C, Nijsten TEC, Grunhagen DJ, Hollestein LM. Validation of a clinicopathological and gene expression profile model for sentinel lymph node metastasis in primary cutaneous melanoma. Br J Dermatol. 2021 May;184(5):944-951. doi: 10.1111/bjd.19499. Epub 2020 Nov 2.

  PMID: 32844403 BACKGROUND

• Lee RJ, Gremel G, Marshall A, Myers KA, Fisher N, Dunn JA, Dhomen N, Corrie PG, Middleton MR, Lorigan P, Marais R. Circulating tumor DNA predicts survival in patients with resected high-risk stage II/III melanoma. Ann Oncol. 2018 Feb 1;29(2):490-496. doi: 10.1093/annonc/mdx717.

  PMID: 29112704 BACKGROUND

• Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4.

  PMID: 35657320 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

All included patients will undergo blood collection for liquid biopsy and biopsy.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elisabetta Pennacchioli, MD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabetta Pennacchioli, MD

CONTACT

0257489485; elisabetta.pennacchioli@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 23, 2024

Record last verified: 2024-06