Molecular Classification in Relation to Prevention of Endometrial Cancer Recurrence and Lifestyle Factors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorLukas Vanek
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of endometrial cancer.
Treated with uterine removal with adequate staging.
Disqualifiers
There are no exclusion criteria in this study.
Trial population
Patients surgically treated with hysterectomy in Department of Gynecology and Obstetrics, Faculty hospital Královské Vinohrady.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Sampled during surgery2
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.
Time frame
Questionnaires filled before surgery, then after 6,12,24 months3
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.
Time frame
Questionnaires filled before surgery, then after 6,12,24 months4
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).
Time frame
Questionnaires filled before surgery, then after 6,12,24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lukas Vanek
Lead sponsor
Faculty Hospital Kralovske Vinohrady
Sponsor institution
National Institute of Public Health, Czech Republic
Collaborator
Source ClinicalTrials.gov