Endometrial CancerMPECNCT06680791
Molecular Classification in Relation to Prevention of Endometrial Cancer Recurrence and Lifestyle Factors
An observational study of Endometrial Cancer and Genetic Predisposition, run by Lukas Vanek at 1 site in Czechia.
Trial summary
Endometrial cancer (EC) is one of the most prevalent cancers in women worldwide with a significantly increasing incidence, especially in developed countries. One of the reasons for the increase in the incidence of this disease is the rising incidence of obesity as the biggest risk factor for the development of this… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer, Genetic Predisposition, Risk Behavior
- How many people
- 280 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Jul 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients surgically treated with hysterectomy in Department of Gynecology and Obstetrics, Faculty hospital Královské Vinohrady.
Who may be able to join
- Clinical diagnosis of endometrial cancer.
- Treated with uterine removal with adequate staging.
Who cannot join
- There are no exclusion criteria in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Faculty Hospital Královské Vinohrady
Prague
Michael Halaška, prof. MUDr., +420 296472368, michael.halaska@fnkv.cz
About this study
Endometrial cancer (EC) is one of the most prevalent cancers in women worldwide with a significantly increasing incidence, especially in developed countries. One of the reasons for the increase in the incidence of this disease is the rising incidence of obesity as the biggest risk factor for the development of this disease. Other important risk factors are hypertension, diabetes mellitus and the general ageing of the population. These risk factors are not only associated with a higher risk of developing the disease, but also, for example, with post-operative complications affecting the quality of life of patients after surgery. The molecular classification of endometrial cancer, which has been introduced into clinical practice in recent years, is currently helping physicians to make treatment decisions for individual patients and predict prognosis. In this project, we would like to focus on the relationship of this molecular classification with genomic mutational signatures detected by whole-exome sequencing and their association with lifestyle risk factors for endometrial cancer (obesity - BMI, hypertension, diabetes mellitus), including the extent of staging lymphadenectomy. Identification and detailed analysis of dominant mutational profiles associated with a specific molecular subtype of EC and their influence on the presence of lifestyle risk factors may have a major impact on both disease development and prevention of disease recurrence. The possible relationship of the mutational profile with the extent of staging lymphadenectomy may help in deciding the extent of this surgical procedure, which subsequently affects the quality of life of patients, especially in patients with high BMI. Given the widespread prevalence of lifestyle risk factors in the developed world, a detailed understanding of the relationship between the genetic profile, its alterations and the prevalence of these risk factors, with potentially major implications for treatment success, is crutial.
Read the detailed description
The main goal of the project is to define specific mutational signatures of endometrial cancer (EC) patients using whole-exome sequencing technology. The relationship between mutational profiles and molecular classification of endometrial cancer will be analyzed in order to improve the stratification of these patients, especially those classified as having a non-specific molecular profile or p53 mutations. At the same time, the association between the dominant mutational profiles of EC patients with the prevalence of lifestyle risk factors such as obesity/BMI, hypertension and diabetes mellitus will be investigated and their incidence is becoming more prevalent in the modern population. Associations between the occurrence of specific mutation profiles with risk factors will be sought and their role in influencing the genetic profile of EC patients will be analyzed. Another aim of the project is to find relationships between specific mutational profiles of patients with the extent of staging lymphadenectomy, which could help to decide the extent of this surgery, which subsequently affects the quality of life of patients, especially in patients with high BMI. The final aim of the project is to establish a methodology to detect mutations arising from dominant specific mutational profiles in circulating tumor DNA (ctDNA) to monitor potential recurrence in patients at high risk of developing and recurrent disease. Overall, the main contribution of the project will be a detailed understanding of the relationship of the genetic profile of EC patients with their molecular subtype, the extent of staging lymphadenectomy and, most importantly, their impact related to the presence of lifestyle risk factors. These factors may be related to the presence of specific dominant mutational profiles subsequently serving as a tool for prognosis, prevention, risk of recurrence but also potential therapeutic targets in women with the presence of any of the lifestyle risk factors.
- Conditions
- Endometrial Cancer, Genetic Predisposition, Risk Behavior
- Keywords
- Endometrial cancer, BMI, Hypertension, Diabetes mellitus, Genetic predispositions
- Medical subject headings
- Endometrial Neoplasms, Genetic Predisposition to Disease, Risk-Taking, Hypertension, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic variants/mutation signatures
Association of dominant signatures with molecular subtype, staging lymphadenectomy, age and lifestyle risk factors as well as their role in recurrence prediction of high-risk patients (obese patients, patients with p53 abnormalities, NSMP patients) and for surgical treatment decisions.
Measured: Sampled during surgery
Quality of life of EC patients using the EORTC QLQ-C30 questionnaire
Analysis of endometrial cancer patients' quality of life undergoing hysterectomy with adequate staging lymphadenectomy by questionary study, specifically questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire is composed of both multi item scales and single item scales. These include five functional scales, three symptom scales, global health status/quality of life scale and six single items.
All scales and single item measures range in score from 0 to 100, high scale represents a higher response level - high score for a functional scale represents a high/healthy level of functioning, high score for the global health status/quality of life represents a high quality of life, high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Questionnaires filled before surgery, then after 6,12,24 months
Quality of life of EC patients using the EORTC QLQ-EN24 questionnaire
Analysis of endometrial cancer patients' quality of life undergoing hysterectomy with adequate staging lymphadenectomy by questionary study, specifically questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24).
The questionnaire is composed of three functional, single-item scales, and 10 symptom scales (both multi-item scales and single-item measures).
All scales and single item measures range in score from 0 to 100, high scale represents a higher response level - high score for a functional scale represents a high/healthy level of functioning, high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Questionnaires filled before surgery, then after 6,12,24 months
Physical activity of EC patients
Analysis of physical activity of EC patients' undergoing hysterectomy with adequate staging lymphadenectomy by questionary study, specifically International Physical Activity Questionnaire - Short Form (IPAQ-SF) questionnaire. This questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. MET (metabolic equivalent) minutes represent the amount of energy expended carrying out physical activity.
Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) depending on MET-minutes (higher score means higher category) and sitting time (higher score means lower category).
Measured: Questionnaires filled before surgery, then after 6,12,24 months
Introduction of methodology of ctDNA detection by digital PCR of consecutive follow-up samples.
Collection of follow-up blood samples at different time-points, at the day of surgery, and then during 6, 12 and 24 months after surgery, methodology optimization for genetic variant detection in ctDNA isolated from follow-up blood samples, analysis of somatic variants resulting from dominant molecular signatures in ctDNA with potential role in EC progress or recurrence, mainly for high-risk EC patients (patients with p53 abnormal expression and NSMP group).
Measured: Collection of blood samples at the day of surgery, then after 6,12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start15 Jul 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lukas Vanek
- Sponsor type
- Other government
- Collaborators
- National Institute of Public Health, Czech Republic
- Responsible party
- Sponsor-investigator, Lukas Vanek, Faculty Hospital Kralovske Vinohrady
- Investigators
- Michael Halaška, prof. MUDr., Principal investigator, Medical director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680791
- Sponsor's protocol ID
- NW24-09-00505
- Acronym
- MPEC
- Status last verified
- Nov 2024
- First submitted
- 10 Jun 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akesson A, Wolmesjo N, Adok C, Milsom I, Dahm-Kahler P. Lymphadenectomy, obesity and open surgery are associated with surgical complications in endometrial cancer. Eur J Surg Oncol. 2021 Nov;47(11):2907-2914. doi: 10.1016/j.ejso.2021.06.034. Epub 2021 Jul 1.
PubMed 34238643Alexandrov LB, Kim J, Haradhvala NJ, Huang MN, Tian Ng AW, Wu Y, Boot A, Covington KR, Gordenin DA, Bergstrom EN, Islam SMA, Lopez-Bigas N, Klimczak LJ, McPherson JR, Morganella S, Sabarinathan R, Wheeler DA, Mustonen V; PCAWG Mutational Signatures Working Group; Getz G, Rozen SG, Stratton MR; PCAWG Consortium. The repertoire of mutational signatures in human cancer. Nature. 2020 Feb;578(7793):94-101. doi: 10.1038/s41586-020-1943-3. Epub 2020 Feb 5.
PubMed 32025018Ashley CW, Da Cruz Paula A, Kumar R, Mandelker D, Pei X, Riaz N, Reis-Filho JS, Weigelt B. Analysis of mutational signatures in primary and metastatic endometrial cancer reveals distinct patterns of DNA repair defects and shifts during tumor progression. Gynecol Oncol. 2019 Jan;152(1):11-19. doi: 10.1016/j.ygyno.2018.10.032. Epub 2018 Nov 8.
PubMed 30415991Ashley CW, Selenica P, Patel J, Wu M, Nincevic J, Lakhman Y, Zhou Q, Shah RH, Berger MF, Da Cruz Paula A, Brown DN, Marra A, Iasonos A, Momeni-Boroujeni A, Alektiar KM, Long Roche K, Zivanovic O, Mueller JJ, Zamarin D, Broach VA, Sonoda Y, Leitao MM, Friedman CF, Jewell E, Reis-Filho JS, Ellenson LH, Aghajanian C, Abu-Rustum NR, Cadoo K, Weigelt B. High-Sensitivity Mutation Analysis of Cell-Free DNA for Disease Monitoring in Endometrial Cancer. Clin Cancer Res. 2023 Jan 17;29(2):410-421. doi: 10.1158/1078-0432.CCR-22-1134.
PubMed 36007103Barry JA, Azizia MM, Hardiman PJ. Risk of endometrial, ovarian and breast cancer in women with polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2014 Sep-Oct;20(5):748-58. doi: 10.1093/humupd/dmu012. Epub 2014 Mar 30.
PubMed 24688118Bhaskaran K, Douglas I, Forbes H, dos-Santos-Silva I, Leon DA, Smeeth L. Body-mass index and risk of 22 specific cancers: a population-based cohort study of 5.24 million UK adults. Lancet. 2014 Aug 30;384(9945):755-65. doi: 10.1016/S0140-6736(14)60892-8. Epub 2014 Aug 13.
PubMed 25129328Bolivar AM, Luthra R, Mehrotra M, Chen W, Barkoh BA, Hu P, Zhang W, Broaddus RR. Targeted next-generation sequencing of endometrial cancer and matched circulating tumor DNA: identification of plasma-based, tumor-associated mutations in early stage patients. Mod Pathol. 2019 Mar;32(3):405-414. doi: 10.1038/s41379-018-0158-8. Epub 2018 Oct 12.
PubMed 30315273Crosbie EJ, Zwahlen M, Kitchener HC, Egger M, Renehan AG. Body mass index, hormone replacement therapy, and endometrial cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2010 Dec;19(12):3119-30. doi: 10.1158/1055-9965.EPI-10-0832. Epub 2010 Oct 28.
PubMed 21030602Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3.
PubMed 35397864Fekete JT, Gyorffy B. ROCplot.org: Validating predictive biomarkers of chemotherapy/hormonal therapy/anti-HER2 therapy using transcriptomic data of 3,104 breast cancer patients. Int J Cancer. 2019 Dec 1;145(11):3140-3151. doi: 10.1002/ijc.32369. Epub 2019 May 7.
PubMed 31020993Grady D, Gebretsadik T, Kerlikowske K, Ernster V, Petitti D. Hormone replacement therapy and endometrial cancer risk: a meta-analysis. Obstet Gynecol. 1995 Feb;85(2):304-13. doi: 10.1016/0029-7844(94)00383-O.
PubMed 7824251Grant BM, Pugh TJ, Oza AM. Molecular Monitoring in Endometrial Cancer-Ready for Prime Time? Clin Cancer Res. 2023 Jan 17;29(2):305-308. doi: 10.1158/1078-0432.CCR-22-2781.
PubMed 36354753Gu 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.
PubMed 33551200Harris HR, Terry KL. Polycystic ovary syndrome and risk of endometrial, ovarian, and breast cancer: a systematic review. Fertil Res Pract. 2016 Dec 5;2:14. doi: 10.1186/s40738-016-0029-2. eCollection 2016.
PubMed 28620541Hlavac V, Holy P, Vaclavikova R, Rob L, Hruda M, Mrhalova M, Cernaj P, Bouda J, Soucek P. Whole-exome sequencing of epithelial ovarian carcinomas differing in resistance to platinum therapy. Life Sci Alliance. 2022 Oct 13;5(12):e202201551. doi: 10.26508/lsa.202201551.
PubMed 36229065
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Classification in Relation to Prevention of Endometrial Cancer Recurrence and Lifestyle Factors
- ClinicalTrials.gov ID
- NCT06680791
- Acronym / sponsor ID
- MPEC / NW24-09-00505
- Conditions
- Endometrial Cancer, Genetic Predisposition, Risk Behavior
- Keywords
- Endometrial cancer, BMI, Hypertension, Diabetes mellitus, Genetic predispositions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Lukas VanekOther government
- Collaborators
- National Institute of Public Health, Czech Republic
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Nov 2024 (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.
Endometrial cancer (EC) is one of the most prevalent cancers in women worldwide with a significantly increasing incidence, especially in developed countries. One of the reasons for the increase in the incidence of this disease is the rising incidence of obesity as the biggest risk factor for the development of this disease. Other important risk factors are hypertension, diabetes mellitus and the general ageing of the population. These risk factors are not only associated with a higher risk of developing the disease, but also, for example, with post-operative complications affecting the quality of life of patients after surgery. The molecular classification of endometrial cancer, which has been introduced into clinical practice in recent years, is currently helping physicians to make treatment decisions for individual patients and predict prognosis. In this project, we would like to focus on the relationship of this molecular classification with genomic mutational signatures detected by whole-exome sequencing and their association with lifestyle risk factors for endometrial cancer (obesity - BMI, hypertension, diabetes mellitus), including the extent of staging lymphadenectomy. Identification and detailed analysis of dominant mutational profiles associated with a specific molecular subtype of EC and their influence on the presence of lifestyle risk factors may have a major impact on both disease development and prevention of disease recurrence. The possible relationship of the mutational profile with the extent of staging lymphadenectomy may help in deciding the extent of this surgical procedure, which subsequently affects the quality of life of patients, especially in patients with high BMI. Given the widespread prevalence of lifestyle risk factors in the developed world, a detailed understanding of the relationship between the genetic profile, its alterations and the prevalence of these risk factors, with potentially major implications for treatment success, is crutial.
Detailed description
The main goal of the project is to define specific mutational signatures of endometrial cancer (EC) patients using whole-exome sequencing technology. The relationship between mutational profiles and molecular classification of endometrial cancer will be analyzed in order to improve the stratification of these patients, especially those classified as having a non-specific molecular profile or p53 mutations. At the same time, the association between the dominant mutational profiles of EC patients with the prevalence of lifestyle risk factors such as obesity/BMI, hypertension and diabetes mellitus will be investigated and their incidence is becoming more prevalent in the modern population. Associations between the occurrence of specific mutation profiles with risk factors will be sought and their role in influencing the genetic profile of EC patients will be analyzed. Another aim of the project is to find relationships between specific mutational profiles of patients with the extent of staging lymphadenectomy, which could help to decide the extent of this surgery, which subsequently affects the quality of life of patients, especially in patients with high BMI. The final aim of the project is to establish a methodology to detect mutations arising from dominant specific mutational profiles in circulating tumor DNA (ctDNA) to monitor potential recurrence in patients at high risk of developing and recurrent disease. Overall, the main contribution of the project will be a detailed understanding of the relationship of the genetic profile of EC patients with their molecular subtype, the extent of staging lymphadenectomy and, most importantly, their impact related to the presence of lifestyle risk factors. These factors may be related to the presence of specific dominant mutational profiles subsequently serving as a tool for prognosis, prevention, risk of recurrence but also potential therapeutic targets in women with the presence of any of the lifestyle risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients surgically treated with hysterectomy in Department of Gynecology and Obstetrics, Faculty hospital Královské Vinohrady.
Key inclusion criteria (2 listed)
- Clinical diagnosis of endometrial cancer.
- Treated with uterine removal with adequate staging.
Key exclusion criteria (1 listed)
- There are no exclusion criteria in this study.
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
Genetic variants/mutation signatures
Time frame: Sampled during surgery
Association of dominant signatures with molecular subtype, staging lymphadenectomy, age and lifestyle risk factors as well as their role in recurrence prediction of high-risk patients (obese patients, patients with p53 abnormalities, NSMP patients) and for surgical treatment decisions.
Quality of life of EC patients using the EORTC QLQ-C30 questionnaire
Time frame: Questionnaires filled before surgery, then after 6,12,24 months
Analysis of endometrial cancer patients' quality of life undergoing hysterectomy with adequate staging lymphadenectomy by questionary study, specifically questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30). The questionnaire is composed of both multi item scales and single item scales. These include five functional scales, three symptom scales, global health status/quality of life scale and six single items. All scales and single item measures range in score from 0 to 100, high scale represents a higher response level - high score for a functional scale represents a high/healthy level of functioning, high score for the global health status/quality of life represents a high quality of life, high score for a symptom scale/item represents a high level of symptomatology/problems.
Quality of life of EC patients using the EORTC QLQ-EN24 questionnaire
Time frame: Questionnaires filled before surgery, then after 6,12,24 months
Analysis of endometrial cancer patients' quality of life undergoing hysterectomy with adequate staging lymphadenectomy by questionary study, specifically questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). The questionnaire is composed of three functional, single-item scales, and 10 symptom scales (both multi-item scales and single-item measures). All scales and single item measures range in score from 0 to 100, high scale represents a higher response level - high score for a functional scale represents a high/healthy level of functioning, high score for a symptom scale/item represents a high level of symptomatology/problems.
Physical activity of EC patients
Time frame: Questionnaires filled before surgery, then after 6,12,24 months
Analysis of physical activity of EC patients' undergoing hysterectomy with adequate staging lymphadenectomy by questionary study, specifically International Physical Activity Questionnaire - Short Form (IPAQ-SF) questionnaire. This questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. MET (metabolic equivalent) minutes represent the amount of energy expended carrying out physical activity. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) depending on MET-minutes (higher score means higher category) and sitting time (higher score means lower category).
Introduction of methodology of ctDNA detection by digital PCR of consecutive follow-up samples.
Time frame: Collection of blood samples at the day of surgery, then after 6,12 and 24 months
Collection of follow-up blood samples at different time-points, at the day of surgery, and then during 6, 12 and 24 months after surgery, methodology optimization for genetic variant detection in ctDNA isolated from follow-up blood samples, analysis of somatic variants resulting from dominant molecular signatures in ctDNA with potential role in EC progress or recurrence, mainly for high-risk EC patients (patients with p53 abnormal expression and NSMP group).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 34238643Akesson A, Wolmesjo N, Adok C, Milsom I, Dahm-Kahler P. Lymphadenectomy, obesity and open surgery are associated with surgical complications in endometrial cancer. Eur J Surg Oncol. 2021 Nov;47(11):2907-2914. doi: 10.1016/j.ejso.2021.06.034. Epub 2021 Jul 1.
- Background: PubMed 32025018Alexandrov LB, Kim J, Haradhvala NJ, Huang MN, Tian Ng AW, Wu Y, Boot A, Covington KR, Gordenin DA, Bergstrom EN, Islam SMA, Lopez-Bigas N, Klimczak LJ, McPherson JR, Morganella S, Sabarinathan R, Wheeler DA, Mustonen V; PCAWG Mutational Signatures Working Group; Getz G, Rozen SG, Stratton MR; PCAWG Consortium. The repertoire of mutational signatures in human cancer. Nature. 2020 Feb;578(7793):94-101. doi: 10.1038/s41586-020-1943-3. Epub 2020 Feb 5.
- Background: PubMed 30415991Ashley CW, Da Cruz Paula A, Kumar R, Mandelker D, Pei X, Riaz N, Reis-Filho JS, Weigelt B. Analysis of mutational signatures in primary and metastatic endometrial cancer reveals distinct patterns of DNA repair defects and shifts during tumor progression. Gynecol Oncol. 2019 Jan;152(1):11-19. doi: 10.1016/j.ygyno.2018.10.032. Epub 2018 Nov 8.
- Background: PubMed 36007103Ashley CW, Selenica P, Patel J, Wu M, Nincevic J, Lakhman Y, Zhou Q, Shah RH, Berger MF, Da Cruz Paula A, Brown DN, Marra A, Iasonos A, Momeni-Boroujeni A, Alektiar KM, Long Roche K, Zivanovic O, Mueller JJ, Zamarin D, Broach VA, Sonoda Y, Leitao MM, Friedman CF, Jewell E, Reis-Filho JS, Ellenson LH, Aghajanian C, Abu-Rustum NR, Cadoo K, Weigelt B. High-Sensitivity Mutation Analysis of Cell-Free DNA for Disease Monitoring in Endometrial Cancer. Clin Cancer Res. 2023 Jan 17;29(2):410-421. doi: 10.1158/1078-0432.CCR-22-1134.
- Background: PubMed 24688118Barry JA, Azizia MM, Hardiman PJ. Risk of endometrial, ovarian and breast cancer in women with polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2014 Sep-Oct;20(5):748-58. doi: 10.1093/humupd/dmu012. Epub 2014 Mar 30.
- Background: PubMed 25129328Bhaskaran K, Douglas I, Forbes H, dos-Santos-Silva I, Leon DA, Smeeth L. Body-mass index and risk of 22 specific cancers: a population-based cohort study of 5.24 million UK adults. Lancet. 2014 Aug 30;384(9945):755-65. doi: 10.1016/S0140-6736(14)60892-8. Epub 2014 Aug 13.
- Background: PubMed 30315273Bolivar AM, Luthra R, Mehrotra M, Chen W, Barkoh BA, Hu P, Zhang W, Broaddus RR. Targeted next-generation sequencing of endometrial cancer and matched circulating tumor DNA: identification of plasma-based, tumor-associated mutations in early stage patients. Mod Pathol. 2019 Mar;32(3):405-414. doi: 10.1038/s41379-018-0158-8. Epub 2018 Oct 12.
- Background: PubMed 21030602Crosbie EJ, Zwahlen M, Kitchener HC, Egger M, Renehan AG. Body mass index, hormone replacement therapy, and endometrial cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2010 Dec;19(12):3119-30. doi: 10.1158/1055-9965.EPI-10-0832. Epub 2010 Oct 28.
- Background: PubMed 35397864Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3.
- Background: PubMed 31020993Fekete JT, Gyorffy B. ROCplot.org: Validating predictive biomarkers of chemotherapy/hormonal therapy/anti-HER2 therapy using transcriptomic data of 3,104 breast cancer patients. Int J Cancer. 2019 Dec 1;145(11):3140-3151. doi: 10.1002/ijc.32369. Epub 2019 May 7.
- Background: PubMed 7824251Grady D, Gebretsadik T, Kerlikowske K, Ernster V, Petitti D. Hormone replacement therapy and endometrial cancer risk: a meta-analysis. Obstet Gynecol. 1995 Feb;85(2):304-13. doi: 10.1016/0029-7844(94)00383-O.
- Background: PubMed 36354753Grant BM, Pugh TJ, Oza AM. Molecular Monitoring in Endometrial Cancer-Ready for Prime Time? Clin Cancer Res. 2023 Jan 17;29(2):305-308. doi: 10.1158/1078-0432.CCR-22-2781.
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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.
Michael Halaška, prof. MUDr. principal investigator
Medical director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Genetic Predisposition, run by Lukas Vanek at 1 site in Czechia.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Halaška, prof. MUDr. (+420 296472368, michael.halaska@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic variants/mutation signatures (time frame: Sampled during surgery). The study lists 5 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 NCT06680791, which also lists 36 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 8 Nov 2024.