Endometrial Cancer International Database

NCT04787159 | Unknown

• 1 other identifier: EC-ID21
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Endometrial Cancer

Keywords

carcinoma of corpus uteri; uterine malignancy; FIGO staging; adenocarcinoma; lymphadenectomy; hystrectomy; prognosis; prediction; machine learning

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women who were diagnosed with endometrial cancer at any stage, of all histological types and grades, between 2008 and 2015.

You may qualify if:

• 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.

You may not qualify if:

• Inadequate information and follow-up for at least 5 years.
• Authorization to use anonymous patient data for research purposes.

Sponsors & Collaborators

• Assiut University: lead
• Middle-East OBGYN Graduate Education Foundation: collaborator

Related 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.

  PMID: 30332563 BACKGROUND

• Lax SF. [New features in the 2014 WHO classification of uterine neoplasms]. Pathologe. 2016 Nov;37(6):500-511. doi: 10.1007/s00292-016-0230-4. German.

  PMID: 27738815 BACKGROUND

• 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.

  PMID: 33451724 BACKGROUND

• 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.

  PMID: 33488325 BACKGROUND

• 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.

  PMID: 30207593 BACKGROUND

• Ignatov A, Ortmann O. Endocrine Risk Factors of Endometrial Cancer: Polycystic Ovary Syndrome, Oral Contraceptives, Infertility, Tamoxifen. Cancers (Basel). 2020 Jul 2;12(7):1766. doi: 10.3390/cancers12071766.

  PMID: 32630728 BACKGROUND

• 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.

  PMID: 30387875 BACKGROUND

• 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 Feb;29(2):299-304. doi: 10.1136/ijgc-2018-000015. Epub 2019 Jan 18.

  PMID: 30659027 BACKGROUND

• 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.

  PMID: 29439179 BACKGROUND

• 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.

  PMID: 32468162 BACKGROUND

• 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. doi: 10.1067/mob.2000.107335.

  PMID: 10871473 BACKGROUND

• 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, Kusters-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.

  PMID: 32413043 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Sherif A Shazly, M.Sc

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif A Shazly, M.Sc

CONTACT

+15075131392; sherif.shazly.mogge@gmail.com

Esraa M Hosny

CONTACT

01112969235; esraa.hosny.mogge@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03