Clinical trial · Observational

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

Gene Expression Profiles and ctDNA for Risk Stratification in Patients With Melanoma Eligible for Lymph Node Sentinel Biopsy (CORRESPOND): an Observational Prospective Study.

NCT06566404CI-TRIAL-00080952CORRESPONDnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Melanoma	Melanoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Model Performance
timeFrame
36 months
description
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)

Secondary outcomes (2)

measure
the estimation of the correlation between ctDNA-positivity and SLNB-positivity
timeFrame
36 months
description
to assess the role of ctDNA-detected mutations in predicting the SLNB status
measure
The estimation of the correlation between MerlinTM/ctDNA-positivity and SLNB-positivity
timeFrame
36 months
description
To assess the role of MerlinTM and ctDNA in predicting micro- or macro- SLNB involvement (micrometastasis \[TNM pathologic stage N1a (pN1a) or N2a (pN2a)\] vs. macrometastasis \[TNM pathologic stage N1b (pN1b) or N2b (pN2b\]).

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 99 Years

Show eligibility criteria text

Inclusion Criteria:

* 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).

Exclusion Criteria:

* SLNB performed;
* receipt of neoadjuvant therapy.

References

Publications (7)

BACKGROUNDLong 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
BACKGROUNDGentilini 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
BACKGROUNDEroglu 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
BACKGROUNDBellomo 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
BACKGROUNDMulder 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.