Lymphadenectomy, obesity and open surgery are associated with surgical complications in endometrial cancer.
Åsa Åkesson, Nina Wolmesjö, Claudia Adok...
https://pubmed.ncbi.nlm.nih.gov/34238643Actively Recruiting
FEMALE
ID06680791
Molecular Classification in Relation to Prevention of Endometrial Cancer Recurrence and Lifestyle Factors
Led by Lukas Vanek · Updated on 2024-11-08
280
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Lukas Vanek
Lead Sponsor
N
National Institute of Public Health, Czech Republic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Endometrial cancer (EC) is a common cancer in women, with rising cases linked to factors like obesity, hypertension, diabetes, and aging. This research aims to study the relationship between the molecular classification of EC and genetic mutation patterns found through whole-exome sequencing. It also explores how lifestyle risk factors and surgical decisions, such as the extent of lymphadenectomy, relate to these genetic profiles and may affect disease development and recurrence. The study focuses on defining specific genetic mutation signatures in EC patients and analyzing their connection to molecular subtypes, especially in cases without a specific profile or with p53 mutations. Researchers will investigate how these mutations associate with lifestyle factors like BMI, hypertension, and diabetes. Additionally, the project seeks to link mutation profiles with the extent of lymphadenectomy surgery and develop methods to detect tumor DNA in blood to monitor recurrence risk. Participants will undergo genetic testing during surgery and complete quality of life and physical activity questionnaires before surgery and at 6, 12, and 24 months afterward. Blood samples for circulating tumor DNA analysis will be collected at surgery and during follow-up visits. The study aims to understand how genetic and lifestyle factors influence EC prognosis and recurrence, helping to guide treatment and prevention strategies over a 2-year follow-up period.
CONDITIONS
Brief Title
Molecular Classification in Relation to Prevention of Endometrial Cancer Recurrence and Lifestyle Factors
Who Can Participate
FEMALE
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of endometrial cancer
- Treated with uterine removal with adequate staging
You will not qualify if you...
- There are no exclusion criteria in this study.
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Day of surgery
Participants undergo surgery to obtain tumor samples and blood samples for genetic and molecular analysis.
1 visit (in-person)
Long-term Monitoring
Duration - 24 months
Participants complete questionnaires and provide blood samples to monitor quality of life, physical activity, and circulating tumor DNA to detect potential recurrence.
Visits at 6, 12, and 24 months after surgery
Trial Site Locations
Total: 1 location
1
Faculty Hospital Královské Vinohrady
Prague, Czechia
Actively Recruiting
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Research Team
M
Michael Halaška, prof. MUDr.
V
Věra Štěpánková
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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https://pubmed.ncbi.nlm.nih.gov/32025018Analysis of mutational signatures in primary and metastatic endometrial cancer reveals distinct patterns of DNA repair defects and shifts during tumor progression.
Charles W Ashley, Arnaud Da Cruz Paula, Rahul Kumar...
https://pubmed.ncbi.nlm.nih.gov/30415991High-Sensitivity Mutation Analysis of Cell-Free DNA for Disease Monitoring in Endometrial Cancer.
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https://pubmed.ncbi.nlm.nih.gov/30315273Body mass index, hormone replacement therapy, and endometrial cancer risk: a meta-analysis.
Emma J Crosbie, Marcel Zwahlen, Henry C Kitchener...
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