Cytology for the diagnosis of endometrial cancer in symptomatic women

Abstract

Objectives: This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows:. To assess the diagnostic accuracy of cytology for endometrial cancer detection in symptomatic women compared to histological diagnosis. Where a participant has not had a histological diagnosis, follow-up of the participant to ensure they have not received a diagnosis of endometrial cancer will be used as a delayed verification reference standard. Secondary objectives To determine the diagnostic accuracy of different cytological sampling techniques for cell collection for the detection of endometrial cancer in symptomatic women compared to histological diagnosis or follow-up as a reference standard. To investigate sources of heterogeneity: Where there are sufficient studies, we will investigate formally the following potential sources of heterogeneity. Characteristics of study population, including age, use of hormonal status and menopausal status. Characteristics of index test (diagnostic test that is being evaluated), including cytology classification system and urogenital sampling site. Date of study (analysis if studies published before or after 2011 due to the introduction of liquid based cytology methods). Methodological quality as assessed by QUADAS-2 tool (QUality Assessment tool for Diagnostic Accuracy Studies), specifically investigating: low risk of bias compared to unclear or high risk of bias on at least one domain; blinding of clinician to results of index tests; study design including single-gate design (disease status of participants is not known on entry into the study) versus two-gate design (where the test is compared in those with a known diagnosis to controls. We will present the cytology preparation method of each study in a separate table so this information can be cross-referenced when interpreting results. The types of cytology preparations are likely to include: direct spreads – sample centrifuged to produce a pellet which is spread directly onto a glass slide and stained; cytospins – a method which uses a cytocentrifuge to produce an even layer of cells on a glass slide from a pellet of sample which can then be stained; membrane filtration – a method which uses a semi-permeable membrane to separate cells from fluid which can be stained; and liquid-based cytology (LBC) – a method used to produce an even, monolayer preparation of cells on a glass slide for staining.