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

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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.

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.

   Measured: Sampled during surgery

2. 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

3. 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

4. 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

5. 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.

1. First posted8 Nov 2024
2. Study start15 Jul 2024
3. Primary completionDec 2027 (estimated)
4. 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.