Abstract
Background: Endometrial cancer is the sixth most common cancer in women with a rising incidence worldwide. Current approaches for the diagnosis and screening of endometrial cancer are invasive, expensive and of moderate diagnostic accuracy, limiting their clinical utility. There is a need for cost-effective and minimally invasive biomarkers to facilitate the early detection and timely management of endometrial cancer. Methods: We analysed blood plasma samples in a cross-sectional diagnostic accuracy study of women with endometrial cancer(n=342), its precursor lesion atypical hyperplasia(n=68) and healthy controls(n=242, total n=652) using attenuated total reflection-Fourier transform infrared(ATR-FTIR) spectroscopy and machine learning algorithms. Findings : We show that blood-based infrared spectroscopy has the potential to detect endometrial cancer with 87% sensitivity and 78% specificity. Its accuracy is highest for type I endometrial cancer, the most common subtype, and for atypical hyperplasia, with sensitivities of 91% and 100%, and specificities of 81% and 88%, respectively. Interpretation: Our large-cohort study shows that a simple blood test could enable the early detection of endometrial cancer of all stages in symptomatic women and provide the basis of a screening tool in high-risk groups. Such a test will not only differentially diagnose endometrial cancer but also detect its precursor lesion atypical hyperplasia, the early recognition of which may allow fertility-sparing management and cancer prevention. Funding Statement: The authors were supported by the Rosemere Cancer Foundation, CAPES–Brazil, Wellcome Trust, Wellbeing of Women, MRC, NIHR and the Department of Health. The views expressed are those of the authors and not necessarily of the funders. Declaration of Interests: The authors declare no potential conflicts of interest. Ethics Approval Statement: All women gave written, informed consent to participate and donated their clinical data and blood samples for future research. Ethical approval was obtained as follows: Weight loss study (North West Research Ethics Committee ref. 12/NW/0050), PROTEC study (Cambridge East Research Ethics Committee ref. 15/EE/0063), PREMIUM study (North West Research Ethics Committee ref. 14/NW/1236), Metformin study (North West Research Ethics Committee ref. 11/NW/0442), PETALS study (NRES Committee North West – Lancaster ref. 15/NW/0733), DETECT study (North West Research Ethics Committee - Greater Manchester 16/NW/0660), and East of England – Cambridge Central Research Ethics Committee ref. 16/EE/0010.
Highlights
There has been a steady rise in the incidence of endometrial cancer in the Western world [1], with the UK reporting a 56% rise over the last two decades [2]
We evaluated whether infrared spectroscopy could detect endometrial cancer and its precursor lesion, atypical hyperplasia, in blood samples
The primary objective of the study was to assess the ability of infrared spectroscopy to detect women with endometrial cancer at its earliest stage as well as its precursor lesion, atypical hyperplasia, using blood samples
Summary
There has been a steady rise in the incidence of endometrial cancer in the Western world [1], with the UK reporting a 56% rise over the last two decades [2]. In 2018, there were 380,000 new cases of endometrial cancer worldwide, rendering it the sixth most common cancer in women [3]. Endometrial cancer typically presents with postmenopausal bleeding, yet only 5–10% of symptomatic women have underlying cancer [6]. Symptoms are usually investigated by measuring endometrial thickness using transvaginal ultrasound scan (TVS) in the first instance [7]. This is an intimate procedure, costly, operator dependent and limited by the scarcity of trained ultrasonographers
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