Minimally and non-invasive methods for early detection and progression of endometrial cancer

Minimally and non-invasive methods for early detection and progression of endometrial cancer - Endometrial cancer early diagnosis and prognosis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48605

Enrollment

200

Registered

2018-06-27

Start date

2018-11-29

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometrial cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cases: - Being older than 18 year - Diagnosis of endometrial cancer (endometrioid, serous, clear cell or mucinous; dedifferentiated; high grade or low grade) - Patients must have signed an approved informed consent;Controls: - Being older than 18 year - Being diagnosed with a benign gynaecological disease, e.g. myoma uteri, prolapsed uterus, or undergoing hysterectomy as prophylactic measure (Lynch syndrome) - Controls will be enrolled if they are-matched with cases (benign disorders may occur more frequently than EC at young age - Subjects must have signed an approved informed consent

Exclusion criteria

Exclusion criteria: Cases: - Being younger than 18 year - Diagnosis of atypical hyperplasia, other types of cancer, sarcoma uteri - Previous diagnosis of EC - Being pregnant at the moment of enrollment - Inability to approve the informed consent form;Controls: - Being younger than 18 year - Being diagnosed with a benign ovarian diseases - Being diagnosed with any malignancy - Previous diagnosis of EC - Being pregnant at the moment of enrollment - Inability to approve the informed consent form

Design outcomes

Primary

Measure	Time frame
Clinical data (via a case report form) and epidemiological data (via a questionnaire) will be collected prospectively. Blood samples will be taken before treatment. In case of hysterectomy, an endometrial biopsy will be collected for immunohistochemical marker analyses. Blood metabolome comprising over 850 metabolites will be analysed by UHPLC/MS, ESI/MS/MS (e.g. chromatography tandem mass spectrometry). Blood proteome including 900 different cancer-related proteins will be analysed in parallel using high content antibody microarrays. Bioinformatics/biostatistical analysis will be used to derive diagnostic and prognostic algorithms based on blood metabolites, proteins and clinical data. Algorithms in the biomarker discovery study will be developed by comparing EC and patients with benign uterine pathologies and by comparing EC patients with low risk and high risk for cancer progression and recurrence.	—

Measure

Time frame

Clinical data (via a case report form) and epidemiological data (via a questionnaire) will be collected prospectively. Blood samples will be taken before treatment. In case of hysterectomy, an endometrial biopsy will be collected for immunohistochemical marker analyses. Blood metabolome comprising over 850 metabolites will be analysed by UHPLC/MS, ESI/MS/MS (e.g. chromatography tandem mass spectrometry). Blood proteome including 900 different cancer-related proteins will be analysed in parallel using high content antibody microarrays. Bioinformatics/biostatistical analysis will be used to derive diagnostic and prognostic algorithms based on blood metabolites, proteins and clinical data. Algorithms in the biomarker discovery study will be developed by comparing EC and patients with benign uterine pathologies and by comparing EC patients with low risk and high risk for cancer progression and recurrence.

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Countries

Netherlands

Outcome results