scholarly journals DEveloping Tests for Endometrial Cancer deTection (DETECT): protocol for a diagnostic accuracy study of urine and vaginal samples for the detection of endometrial cancer by cytology in women with postmenopausal bleeding

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e050755
Author(s):  
Eleanor R Jones ◽  
Suzanne Carter ◽  
Helena O'Flynn ◽  
Kelechi Njoku ◽  
Chloe E Barr ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Diagnostic Accuracy ◽  
Cancer Detection ◽  
Transvaginal Ultrasound ◽  
Primary Objective ◽  
Endometrial Biopsy ◽  
Test Accuracy ◽  
Diagnostic Accuracy Study ◽  
Postmenopausal Bleeding ◽  
Accuracy Study

IntroductionPostmenopausal bleeding (PMB), the red flag symptom for endometrial cancer, triggers urgent investigation by transvaginal ultrasound scan, hysteroscopy and/or endometrial biopsy. These investigations are costly, invasive and often painful or distressing for women. In a pilot study, we found that voided urine and non-invasive vaginal samples from women with endometrial cancer contain malignant cells that can be identified by cytology. The aim of the DEveloping Tests for Endometrial Cancer deTection (DETECT) Study is to determine the diagnostic test accuracy of urine and vaginal cytology for endometrial cancer detection in women with PMB.Methods and analysisThis is a multicentre diagnostic accuracy study of women referred to secondary care with PMB. Eligible women will be asked to provide a self-collected voided urine sample and a vaginal sample collected with a Delphi screener before routine clinical procedures. Pairs of specialist cytologists, blinded to participant cancer status, will assess and classify samples independently, with differences settled by consensus review or involving a third cytologist. Results will be compared with clinical outcomes from standard diagnostic tests. A sample size of 2000 women will have 80% power to establish a sensitivity of vaginal samples for endometrial cancer detection by cytology of ≥85%±7%, assuming 5% endometrial cancer prevalence. The primary objective is to determine the diagnostic accuracy of urogenital samples for endometrial cancer detection by cytology. Secondary objectives include the acceptability of urine and vaginal sampling to women.Ethics and disseminationThis study has been approved by the North West–Greater Manchester West Research Ethics Committee (16/NW/0660) and the Health Research Authority. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via charity websites.Trial registration numberISRCTN58863784.

scholarly journals Clear Cell Carcinoma of the Endometrium in a Patient Presenting with Postmenopausal Bleeding but Negative Endometrial Biopsy

2021 ◽  
pp. 1768-1772
Author(s):  
Swechchha Silwal ◽  
Sumeet Kumar Yadav ◽  
Benedict Amalraj ◽  
Mohamed Mandeel ◽  
Geetha Krishnamoorthy
Keyword(s):  
Endometrial Cancer ◽  
Cell Carcinoma ◽  
Clear Cell ◽  
Clear Cell Carcinoma ◽  
Endometrial Thickness ◽  
Transvaginal Ultrasound ◽  
Endometrial Biopsy ◽  
Postmenopausal Bleeding ◽  
Gynecological Malignancy ◽  
The Usa

Endometrial carcinoma is the most common gynecological malignancy in the USA with approximately 66,570 cases and 12,940 deaths in 2020. Clear cell carcinoma (CCC) of the endometrium is an estrogen-independent type II endometrial cancer which accounts for <5% of endometrial cancer. When diagnosed roughly, 45% of patients have extrauterine metastases. Current American College of Obstetrics and Gynecology guidelines recommend transvaginal ultrasound for postmenopausal bleeding and a biopsy for those with endometrial thickness >5 mm. However, we present a case of a postmenopausal woman with a history of fibroid where endometrial biopsy has failed to make diagnosis twice. Hence, further testing should be performed in patients with unexplained postmenopausal bleeding including vaginal hysterectomy with lymph node dissection.

Ultrasonographic 3D Evaluation in the Diagnosis of Bladder Endometriosis: A Prospective Comparative Diagnostic Accuracy Study

2021 ◽  
pp. 1-8
Author(s):  
Fabio Barra ◽  
Franco Alessandri ◽  
Carolina Scala ◽  
Simone Ferrero
Keyword(s):  
Diagnostic Accuracy ◽  
Three Dimensional ◽  
3D Ultrasound ◽  
Diagnostic Accuracy Study ◽  
Extensive Experience ◽  
Deep Endometriosis ◽  
3D Reconstructions ◽  
Analysis Group ◽  
Bladder Endometriosis ◽  
Accuracy Study

<b><i>Objective:</i></b> The use of three-dimensional (3D) transvaginal ultrasonography (TVS) has been investigated for the diagnosis of deep endometriosis (DE). This study aimed to evaluate if 3D reconstructions improve the performance of TVS) in assessing the presence and characteristics of bladder endometriosis (BE). <b><i>Design:</i></b> This was a single-center comparative diagnostic accuracy study. <b><i>Participants/Materials, Setting, Methods:</i></b> Patients referred to our institution (Piazza della Vittoria 14 Srl, Genova, Italy) with clinical suspicion of DE were included. In case of surgery, women underwent systematic preoperative ultrasonographic imaging; an experienced sonographer performed a conventional TVS; another experienced sonographer, blinded to results of the previous exam, performed TVS, with the addition of 3D modality. The presence and characteristics of BE nodules were described in accord with International DE Analysis group consensus. Ultrasound data were compared with surgical and histological results. <b><i>Results:</i></b> Overall, BE was intraoperatively found in 34 out of 194 women who underwent surgery for DE (17.5%; 95% confidence interval: 12.8–23.5%). TVS without and with 3D reconstructions were able to detect endometriotic BE in 82.2% (<i>n</i> = 28/34) and 85.3% (<i>n</i> = 29/34) of the cases (<i>p</i> = 0.125). Both the exams similarly estimated the largest diameter of BE (<i>p</i> = 0.652) and the distance between the endometriotic nodule and the closest ureteral meatus (<i>p</i> = 0.341). However, TVS with 3D reconstructions was more precise in estimating the volume of BE (<i>p</i> = 0.031). In one case (2.9%), TVS without and with 3D reconstructions detected the infiltration of the intramural ureter, which was confirmed at surgery and required laparoscopic ureterovesical reimplantation. <b><i>Limitations:</i></b> The extensive experience of the gynecologists performing the ultrasonographic scans, the lack of prestudy power analysis, and the population selected, which may have been influenced by the position of the institution as a referral center specialized in the treatment of severe endometriosis, are limitations of the current study. <b><i>Conclusion:</i></b> Our results demonstrated the high accuracy of ultrasound for diagnosing BE. The addition of 3D reconstructions does not improve the performance of TVS in diagnosing the presence and characteristics of BE. However, the volume of BE may be more precisely assessed by 3D ultrasound.

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