Molecular Classification in Relation to Prevention of Endometrial Cancer Recurrence and Lifestyle Factors

NCT06680791 | Recruiting

• 1 other identifier: NW24-09-00505
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Endometrial Cancer; Genetic Predisposition; Risk Behavior

Keywords

Endometrial cancer; BMI; Hypertension; Diabetes mellitus; Genetic predispositions

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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).

  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).

  Collection of blood samples at the day of surgery, then after 6,12 and 24 months

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients surgically treated with hysterectomy in Department of Gynecology and Obstetrics, Faculty hospital Královské Vinohrady.

You may qualify if:

• Clinical diagnosis of endometrial cancer.
• Treated with uterine removal with adequate staging.

Sponsors & Collaborators

• Lukas Vanek: lead
• National Institute of Public Health (NIPH), Czech Republic: collaborator

Study Sites (1)

Faculty Hospital Královské Vinohrady

Prague, Czechia

RECRUITING

Related Publications (36)

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Biospecimen

Retention: SAMPLES WITH DNA

Patients with endometrial cancer

MeSH Terms

Conditions

Endometrial Neoplasms; Genetic Predisposition to Disease; Risk-Taking; Hypertension; Diabetes Mellitus

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; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael Halaška, prof. MUDr.

  Medical director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Halaška, prof. MUDr.

CONTACT

+420 296472368; michael.halaska@fnkv.cz

Věra Štěpánková

CONTACT

+42026716 2739; vera.stepankova@fnkv.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor, Department of Gynecology and Obstetrics

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: November 8, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

CZ (1)