Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Endometrial cancer is one of the most common malignancies of the reproductive system. The incidence of endometrial cancer has increased in recent years. No effective, low-cost screening method for populations at high risk exists.
The traditional methods of endometrial cancer screening and diagnosis (segmented scraping and hysteroscopic biopsy) are invasive examinations with high medical costs. It is urgent to establish a reasonable, effective, economical, and non-invasive endometrial cancer screening strategy. This study aims to evaluate the effectiveness and feasibility of transvaginal ultrasound and microscale endometrial sampling biopsy in screening for endometrial precancerous lesions and endometrial cancer among high-risk populations in China, and to conduct cost-effectiveness analysis of different screening strategy, ultimately guiding the development of screening strategies that are suitable for high-risk populations in China.
The enrolled patients underwent simultaneous transvaginal ultrasound examination and microscale endometrial sampling biopsy.
After enrollment, a vaginal ultrasound examination was performed to record the thickness of the endometrium, whether there were uterine cavity masses, endometrial unevenness, and endometrial blood flow. If any of the following occurs, it is considered a positive screening result:
A. Premenopausal women with endometrial thickness greater than 8mm B. Postmenopausal endometrial thickness>4mm C. Uneven endometrium D. Abnormal echo in the uterine cavity E. Endometrium or uterine cavity with abundant blood flow (RI ≤ 0.45) If the above situation does not occur, it is considered as negative for transvaginal ultrasound screening.
After completing the transvaginal ultrasound examination, the patient used Li rush in the diagnostic room to obtain endometrial tissue samples and conduct pathological examination of the endometrial tissue.
A. Not satisfied with the specimen (mucus or hemorrhagic necrotic tissue) or insufficient sampling (only a small amount of endometrial tissue can be seen, less than 5 endometrial glands cannot be diagnosed by pathology) or no endometrial components are found, and a small amount of cervical tissue is scraped B. Normal proliferative phase, secretory phase, atrophic endometrium C. Without atypical endometrial proliferative lesions D. Suspected malignant tumor cells and tissue components E. Atypical endometrial hyperplasia/EIN or endometrial cancer If result A appears, it is considered a failure to obtain the sample, and if result B appears, it is considered a negative screening result. C. The results of D and E are considered positive for screening.
If there is a positive result in either vaginal ultrasound or endometrial microstructural pathological examination, further hysteroscopic staging and scraping of endometrial tissue pathological examination shall be performed.
follow-up
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high risk population | Experimental | The enrolled patients underwent simultaneous transvaginal ultrasound examination and microscale endometrial sampling biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transvaginal ultrasound and microscale endometrial sampling biopsy | Diagnostic Test | Transvaginal ultrasound and endometrial micro tissue pathology examination are used concurrently for endometrial cancer screening in high-risk populations. The specificity, sensitivity, and optimal combination of the two screening methods are clarified, and a cost-effectiveness analysis is conducted on different screening strategy. |
| Measure | Description | Time Frame |
|---|---|---|
| sensitivity and specificity | Evaluate the sensitivity and specificity of transvaginal ultrasound and endometrial microstructural pathology examination for endometrial cancer screening in high-risk populations, and determine the most effective screening mode | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| cost-effectiveness analysis | Using Quality Adjusted Life Year (QALY) as the effectiveness indicator, screening expenses (screening organization management expenses, testing and evaluation expenses, personal direct expenses, and personal indirect expenses) and treatment expenses (including hospitalization expenses, outpatient expenses, direct non medical expenses, and indirect expenses) as the cost of expenditure, Calculate the cost-effectiveness ratio of different screening modes (single B-ultrasound, single endometrial micro tissue examination, B-ultrasound+endometrial micro tissue examination, B-ultrasound endometrial micro tissue examination), and calculate the cost of each extended QALY for each group and the incremental cost-effectiveness ratio between each group, and compare it with the willingness to pay value (budget line). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo Zhang, doctor | Contact | +861088324384 | zhangguo-2005@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianliu Wang, doctor | Peking University People's Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 33551200 | Background | Gu B, Shang X, Yan M, Li X, Wang W, Wang Q, Zhang C. Variations in incidence and mortality rates of endometrial cancer at the global, regional, and national levels, 1990-2019. Gynecol Oncol. 2021 May;161(2):573-580. doi: 10.1016/j.ygyno.2021.01.036. Epub 2021 Feb 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D004714 | Endometrial Hyperplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 years |
| 11577479 | Background | Smith RA, von Eschenbach AC, Wender R, Levin B, Byers T, Rothenberger D, Brooks D, Creasman W, Cohen C, Runowicz C, Saslow D, Cokkinides V, Eyre H; ACS Prostate Cancer Advisory Committee, ACS Colorectal Cancer Advisory Committee, ACS Endometrial Cancer Advisory Committee. American Cancer Society guidelines for the early detection of cancer: update of early detection guidelines for prostate, colorectal, and endometrial cancers. Also: update 2001--testing for early lung cancer detection. CA Cancer J Clin. 2001 Jan-Feb;51(1):38-75; quiz 77-80. doi: 10.3322/canjclin.51.1.38. |
| 30364388 | Background | Emons G, Steiner E, Vordermark D, Uleer C, Bock N, Paradies K, Ortmann O, Aretz S, Mallmann P, Kurzeder C, Hagen V, van Oorschot B, Hocht S, Feyer P, Egerer G, Friedrich M, Cremer W, Prott FJ, Horn LC, Prompeler H, Langrehr J, Leinung S, Beckmann MW, Kimmig R, Letsch A, Reinhardt M, Alt-Epping B, Kiesel L, Menke J, Gebhardt M, Steinke-Lange V, Rahner N, Lichtenegger W, Zeimet A, Hanf V, Weis J, Mueller M, Henscher U, Schmutzler RK, Meindl A, Hilpert F, Panke JE, Strnad V, Niehues C, Dauelsberg T, Niehoff P, Mayr D, Grab D, Kreissl M, Witteler R, Schorsch A, Mustea A, Petru E, Hubner J, Rose AD, Wight E, Tholen R, Bauerschmitz GJ, Fleisch M, Juhasz-Boess I, Sigurd L, Runnebaum I, Tempfer C, Nothacker MJ, Blodt S, Follmann M, Langer T, Raatz H, Wesselmann S, Erdogan S. Interdisciplinary Diagnosis, Therapy and Follow-up of Patients with Endometrial Cancer. Guideline (S3-Level, AWMF Registry Nummer 032/034-OL, April 2018) - Part 1 with Recommendations on the Epidemiology, Screening, Diagnosis and Hereditary Factors of Endometrial Cancer. Geburtshilfe Frauenheilkd. 2018 Oct;78(10):949-971. doi: 10.1055/a-0713-1218. Epub 2018 Oct 19. |
| 32349386 | Background | Saccardi C, Vitagliano A, Marchetti M, Lo Turco A, Tosatto S, Palumbo M, De Lorenzo LS, Vitale SG, Scioscia M, Noventa M. Endometrial Cancer Risk Prediction According to Indication of Diagnostic Hysteroscopy in Post-Menopausal Women. Diagnostics (Basel). 2020 Apr 27;10(5):257. doi: 10.3390/diagnostics10050257. |
| 22081523 | Background | Burnley C, Dudding N, Parker M, Parsons P, Whitaker CJ, Young W. Glandular neoplasia and borderline endocervical reporting rates before and after conversion to the SurePath(TM) liquid-based cytology (LBC) system. Diagn Cytopathol. 2011 Dec;39(12):869-74. doi: 10.1002/dc.21471. Epub 2010 Nov 2. |
| 33412129 | Result | Matsuo K, Mandelbaum RS, Matsuzaki S, Klar M, Roman LD, Wright JD. Ovarian conservation for young women with early-stage, low-grade endometrial cancer: a 2-step schema. Am J Obstet Gynecol. 2021 Jun;224(6):574-584. doi: 10.1016/j.ajog.2020.12.1213. Epub 2021 Jan 4. |
| 30675969 | Result | Kawaguchi R, Matsumoto K, Akira S, Ishitani K, Iwasaku K, Ueda Y, Okagaki R, Okano H, Oki T, Koga K, Kido M, Kurabayashi T, Kuribayashi Y, Sato Y, Shiina K, Takai Y, Tanimura S, Chaki O, Terauchi M, Todo Y, Noguchi Y, Nose-Ogura S, Baba T, Hirasawa A, Fujii T, Fujii T, Maruyama T, Miyagi E, Yanagida K, Yoshino O, Iwashita M, Maeda T, Minegishi T, Kobayashi H. Guidelines for office gynecology in Japan: Japan Society of Obstetrics and Gynecology (JSOG) and Japan Association of Obstetricians and Gynecologists (JAOG) 2017 edition. J Obstet Gynaecol Res. 2019 Apr;45(4):766-786. doi: 10.1111/jog.13831. Epub 2019 Jan 24. |
| 30147382 | Result | Aue-Aungkul A, Kleebkaow P, Kietpeerakool C. Incidence and risk factors for insufficient endometrial tissue from endometrial sampling. Int J Womens Health. 2018 Aug 15;10:453-457. doi: 10.2147/IJWH.S172696. eCollection 2018. |
| 29953784 | Result | Li MX, Zhou R, Liu C, Shen DH, Zhao LJ, Wang JL, Wei LH. Direct uterine sampling using the SAP-l sampler device to detect endometrial lesions during histopathological examination. Eur J Gynaecol Oncol. 2017;38(2):221-226. |
| 33009021 | Result | Zhang G, Wang Y, Liang XD, Zhou R, Sun XL, Wang JL, Wei LH. Microscale endometrial sampling biopsy in detecting endometrial cancer and atypical hyperplasia in a population of 1551 women: a comparative study with hysteroscopic endometrial biopsy. Chin Med J (Engl). 2020 Sep 30;134(2):193-199. doi: 10.1097/CM9.0000000000001109. |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |