Endometrial CancerECIDNCT04787159
Endometrial Cancer International Database
An observational study of Endometrial Cancer, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women who were diagnosed with endometrial cancer at any stage, of all histological types and grades, between 2008 and 2015.
Who may be able to join
- 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.
Who cannot join
- Inadequate information and follow-up for at least 5 years.
- Authorization to use anonymous patient data for research purposes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study
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).
Read the detailed 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.
- Conditions
- Endometrial Cancer
- Keywords
- carcinoma of corpus uteri, uterine malignancy, FIGO staging, adenocarcinoma, lymphadenectomy, hystrectomy, prognosis, prediction, machine learning
- Medical subject headings
- Endometrial Neoplasms, Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 1 year
Number of women who are alive after cancer treatment divided by total number of patients at study onset
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Middle-East OBGYN Graduate Education Foundation
- Responsible party
- Principal investigator, Sherif Abdelkarim Mohammed Shazly, Assiut University
- Investigators
- Sherif A Shazly, M.Sc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787159
- Sponsor's protocol ID
- EC-ID21
- Acronym
- ECID
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30332563Lax 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.
PubMed 27738815Hamilton 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.
PubMed 33451724Soja 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.
PubMed 33488325Bray 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.
PubMed 30207593Ignatov 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.
PubMed 32630728Raglan 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.
PubMed 30387875Kruse 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.
PubMed 30659027Murali 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.
PubMed 29439179Petousis 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.
PubMed 32468162Mariani 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.
PubMed 10871473Reijnen 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.
PubMed 32413043
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study
- ClinicalTrials.gov ID
- NCT04787159
- Acronym / sponsor ID
- ECID / EC-ID21
- Conditions
- Endometrial Cancer
- Keywords
- carcinoma of corpus uteri, uterine malignancy, FIGO staging, adenocarcinoma, lymphadenectomy, hystrectomy, prognosis, prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Middle-East OBGYN Graduate Education Foundation
- Study start
- May 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women who were diagnosed with endometrial cancer at any stage, of all histological types and grades, between 2008 and 2015.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Inadequate information and follow-up for at least 5 years.
- Authorization to use anonymous patient data for research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival at 1 year
Time frame: At 1 year
Number of women who are alive after cancer treatment divided by total number of patients at study onset
Overall survival at 3 years
Time frame: At 3 years
Number of women who are alive after cancer treatment divided by total number of patients at study onset
Overall survival at 5 years
Time frame: At 5 years
Number of women who are alive after cancer treatment divided by total number of patients at study onset
disease free survival at 1 year
Time frame: At 1 year
Number of women who are are disease free after cancer treatment divided by total number of patients at study onset
disease free survival at 3 years
Time frame: At 3 years
Number of women who are are disease free after cancer treatment divided by total number of patients at study onset
disease free survival at 5 years
Time frame: At 5 years
Number of women who are are disease free after cancer treatment divided by total number of patients at study onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Background: PubMed 30332563Bell 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.
- Background: PubMed 27738815Lax 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.
- Background: PubMed 33451724Hamilton 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.
- Background: PubMed 33488325Soja 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.
- Background: PubMed 30207593Bray 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.
- Background: PubMed 32630728Ignatov 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.
- Background: PubMed 30387875Raglan 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.
- Background: PubMed 30659027Kruse 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.
- Background: PubMed 29439179Murali 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.
- Background: PubMed 32468162Petousis 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.
- Background: PubMed 10871473Mariani 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.
- Background: PubMed 32413043Reijnen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif A Shazly, M.Sc principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif A Shazly, M.Sc (+15075131392, sherif.shazly.mogge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at 1 year (time frame: At 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787159, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.