Endometrial Cancer International Database

Endometrial Cancer Clinical Trial

— ECID  

Official title:

Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04787159
• Other study ID #: EC-ID21
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: March 2022

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: Sherif A Shazly, M.Sc
• Phone: +15075131392
• Email: sherif.shazly.mogge[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project aims to determining prognostic factors and individualizing management decision per patient characteristics and endometrial cancer features. This study will include at least 10 centers from different countries that present at least Europe, South America, Asia, and Africa. Data will be retrospectively collected from January 2008 to December 2015 with a total follow-up of at least 5 years (December 2020).

Description:

Endometrial cancer (EC) or carcinoma of corpus uteri is a neoplastic change, mostly adenocarcinoma, arising from uterine columnar epithelial lining. Abnormal uterine bleeding is the main presenting symptom especially in postmenopausal women. EC is estimated to be the seventh most commonly diagnosed cancer in women. It is considered the 16th leading cause of death in women with cancer worldwide, with 382 000 estimated new cases and 89 900 deaths in 2018. Factors as obesity, parity, diabetes mellitus, unopposed estrogen exposure, genetics and hormonal therapies are recognizable risks for EC. Other factors as chronic comorbidities, tumor size and organ metastasis influence staging, prognosis, and management protocols.

FIGO staging has been adopted as the standard classification system in the management of endometrial cancer. However, this staging system does not consider all factors that affect treatment decision and prognosis including but not limited to patient demographics, tumor grade, and lymphovascular space invasion. In addition, some interventions are still debatable particularly in the presence of intermediate disease e.g, grade II early EC. Available evidence supports combined pelvic and para-aortic lymphadenectomy in management of patients with EC. However, combined pelvic and para-aortic lymphadenectomy carry the risk of long term morbidities as lymphedema. Thus, hysterectomy alone as management plan is suggested in patients with low risk EC. More comprehensive studies of the multiple confounders that determine patient's risk are essential to reach an individually adjusted management plans and to predict prognosis of each individual case. Therefore, availability of large multicenter studies will provide robust evidence regarding optimal management of EC and hence, improve treatment outcome and prognosis particularly in the era of machine learning and artificial intelligence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Women diagnosed with endometrial cancer, between 2008 and 2015.

• Women should be diagnosed and managed by the corresponding center.

• Patients with adequate clinical and pathological data.

Exclusion Criteria:

• Inadequate information and follow-up for at least 5 years.

• Authorization to use anonymous patient data for research purposes.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Middle East OBGYN graduate education Foundation

References & Publications (12)

Bell DW, Ellenson LH. Molecular Genetics of Endometrial Carcinoma. Annu Rev Pathol. 2019 Jan 24;14:339-367. doi: 10.1146/annurev-pathol-020117-043609. Epub 2018 Oct 17. Review. — View Citation

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

Hamilton CA, Pothuri B, Arend RC, Backes FJ, Gehrig PA, Soliman PT, Thompson JS, Urban RR, Burke WM. Endometrial cancer: A society of gynecologic oncology evidence-based review and recommendations, part II. Gynecol Oncol. 2021 Mar;160(3):827-834. doi: 10.1016/j.ygyno.2020.12.024. Epub 2021 Jan 13. Review. — View Citation

Ignatov A, Ortmann O. Endocrine Risk Factors of Endometrial Cancer: Polycystic Ovary Syndrome, Oral Contraceptives, Infertility, Tamoxifen. Cancers (Basel). 2020 Jul 2;12(7). pii: E1766. doi: 10.3390/cancers12071766. Review. — View Citation

Kruse AJ, Ter Brugge HG, de Haan HH, Van Eyndhoven HW, Nijman HW. Vaginal hysterectomy with or without bilateral salpingo-oophorectomy may be an alternative treatment for endometrial cancer patients with medical co-morbidities precluding standard surgical procedures: a systematic review. Int J Gynecol Cancer. 2019 Jan 18. pii: ijgc-2018-000015. doi: 10.1136/ijgc-2018-000015. [Epub ahead of print] — View Citation

Lax SF. [New features in the 2014 WHO classification of uterine neoplasms]. Pathologe. 2016 Nov;37(6):500-511. Review. German. — View Citation

Mariani A, Webb MJ, Keeney GL, Haddock MG, Calori G, Podratz KC. Low-risk corpus cancer: is lymphadenectomy or radiotherapy necessary? Am J Obstet Gynecol. 2000 Jun;182(6):1506-19. — View Citation

Murali R, Delair DF, Bean SM, Abu-Rustum NR, Soslow RA. Evolving Roles of Histologic Evaluation and Molecular/Genomic Profiling in the Management of Endometrial Cancer. J Natl Compr Canc Netw. 2018 Feb;16(2):201-209. doi: 10.6004/jnccn.2017.7066. Review. — View Citation

Petousis S, Christidis P, Margioula-Siarkou C, Papanikolaou A, Dinas K, Mavromatidis G, Guyon F, Rodolakis A, Vergote I, Kalogiannidis I. Combined pelvic and para-aortic is superior to only pelvic lymphadenectomy in intermediate and high-risk endometrial cancer: a systematic review and meta-analysis. Arch Gynecol Obstet. 2020 Jul;302(1):249-263. doi: 10.1007/s00404-020-05587-2. Epub 2020 May 28. — View Citation

Raglan O, Kalliala I, Markozannes G, Cividini S, Gunter MJ, Nautiyal J, Gabra H, Paraskevaidis E, Martin-Hirsch P, Tsilidis KK, Kyrgiou M. Risk factors for endometrial cancer: An umbrella review of the literature. Int J Cancer. 2019 Oct 1;145(7):1719-1730. doi: 10.1002/ijc.31961. Epub 2019 Feb 20. Review. — View Citation

Reijnen C, Gogou E, Visser NCM, Engerud H, Ramjith J, van der Putten LJM, van de Vijver K, Santacana M, Bronsert P, Bulten J, Hirschfeld M, Colas E, Gil-Moreno A, Reques A, Mancebo G, Krakstad C, Trovik J, Haldorsen IS, Huvila J, Koskas M, Weinberger V, Bednarikova M, Hausnerova J, van der Wurff AAM, Matias-Guiu X, Amant F; ENITEC Consortium, Massuger LFAG, Snijders MPLM, Küsters-Vandevelde HVN, Lucas PJF, Pijnenborg JMA. Preoperative risk stratification in endometrial cancer (ENDORISK) by a Bayesian network model: A development and validation study. PLoS Med. 2020 May 15;17(5):e1003111. doi: 10.1371/journal.pmed.1003111. eCollection 2020 May. — View Citation

Soja M, Masternak M, Piwowarczyk I, Janas L, Szyllo K, Nowak M. Analysis of the results of invasive diagnostic procedures in patients referred to gynecologic department due to abnormal uterine bleeding. Prz Menopauzalny. 2020 Dec;19(4):155-159. doi: 10.5114/pm.2020.101942. Epub 2021 Jan 7. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival at 1 year	Number of women who are alive after cancer treatment divided by total number of patients at study onset	At 1 year
Primary	Overall survival at 3 years	Number of women who are alive after cancer treatment divided by total number of patients at study onset	At 3 years
Primary	Overall survival at 5 years	Number of women who are alive after cancer treatment divided by total number of patients at study onset	At 5 years
Primary	disease free survival at 1 year	Number of women who are are disease free after cancer treatment divided by total number of patients at study onset	At 1 year
Primary	disease free survival at 3 years	Number of women who are are disease free after cancer treatment divided by total number of patients at study onset	At 3 years
Primary	disease free survival at 5 years	Number of women who are are disease free after cancer treatment divided by total number of patients at study onset	At 5 years