Tests to assist in the staging of cutaneous melanoma: a generic protocol

Abstract

This is a protocol for a Cochrane Review (Diagnostic test accuracy). The objectives are as follows: To determine the diagnostic accuracy of SLNB for the detection of nodal metastases (in the investigated nodal basin) for the staging of cutaneous invasive melanoma. To determine the diagnostic accuracy of imaging tests for the detection of any metastasis in the primary staging of cutaneous invasive melanoma (i.e. staging at presentation). To determine the diagnostic accuracy of imaging tests for the detection of any metastasis in the staging of recurrence in cutaneous invasive melanoma (i.e. re-staging prompted by findings on routine follow-up). To determine the diagnostic accuracy of imaging tests for the detection of nodal metastases in the staging of cutaneous invasive melanoma. To determine the diagnostic accuracy of imaging tests for the detection of distant metastases in the staging of cutaneous invasive melanoma. These will be estimated separately for those undergoing primary staging and those who have experienced a disease recurrence. Investigation of sources of heterogeneity: We will consider a range of potential sources of heterogeneity for investigation in each individual test review. These may vary between reviews but may include the following. i. Population characteristics: * AJCC stage of disease * Sentinel lymph node status (for imaging studies only) * Clinical nodal status (for imaging studies only) * Primary tumour site (head and neck, trunk, limb, and other) ii. Index test characteristics: * Differences in test positivity thresholds (e.g. for SLNB, the tracer threshold for a 'hot' versus 'cold' node) * Other relevant test characteristics as appropriate to the test under consideration iii. Reference standard characteristics: * Reference standard used (histology, clinical or imaging-based follow-up; concurrent imaging-based reference standard) iv. Study quality: * Consecutive or random sample of participants recruited * Index test interpreted, blinded to the reference standard result * Index test interpreted, blinded to the result of any other index test * Presence of partial or differential verification bias (whereby only a sample of those subject to the index test are verified by the reference test or by the same reference test, with selection dependent on the index test result) * Use of an adequate reference standard * Overall risk of bias We will examine the quality and quantity of research evidence available on the effectiveness of each index test for the primary target condition and make recommendations regarding where further research might be required