MeD-seq, a novel assay for genome-wide DNA methylation profiling in developing predictive biomarkers of gynaecological cancer and endometriosis

Recruiting

• Conditions: all female genital cancers; cervical cancer; ovarian cancer. uterine cancer and endometriosis; vulva cancer; 10013364

• Registration Number: NL-OMON51586
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

1. Gynaecological cancer or endometriosis patients>= 18 years undergoing
gynaecological examination
2. Healthy women >= 18 years undergoing gynaecological surgery
3. Healthy women >= 18 years undergoing gynaecological examination
4. Written informed consent

Exclusion Criteria

1. Women not able to read or understand the PIF (patient information).
2. Women not willing to participate.
3. Other malignancies in the past 5 years, except for basal cell carcinoma of
the skin

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To develop a test for early detection of female genital cancer and<br /><br>endometriosis using Pap smears and blood.<br /><br>2. The DNA methylation atlas of normal female genital cell types. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Development of a DNA methylation atlas of the healthy female genital cell types<br /><br>(vulva, vagina, cervix, uterus, tubes and ovaries) using the MeD-seq<br /><br>technology.</p><br>