June 2022, NEW DATA – Methylation performance in pregnant women with CIN3
Evaluation of FAM19A4/miR124-2 methylation performance in the management of CIN3 diagnosed pregnant women.
Publication: DOI: https://onlinelibrary.wiley.com/doi/epdf/10.1002/ijc.34153
NOVELTY AND IMPACT
Pregnant women diagnosed with CIN3 pose a big challenge to their gynecologists. To find an individual treatment and management that do no harm to neither the woman nor her unborn child remains a challenge.
This study shows that a negative FAM19A4/miR124-2 methylation test can rule out progressive CIN3 and cervical cancer and that a negative FAM19A4/mir124-2 methylation test can help the clinician by safely managing these pregnant women with conservative follow-up until after delivery.
STUDY DESIGN
The performance of the FAM19A4/miR124-2 methylation test for molecular triage on FFPE samples of CIN3+-diagnosed pregnant women with known clinical course over time as well in a cross-sectional setting. In this German multicenter retrospective study biopsy material was collected from pregnant women diagnosed with cervical cancer (n=16), with CIN3 that progressed to cancer during pregnancy (n=7), with CIN3 that regressed to CIN1 or less within 6 months after delivery (n=41), without CIN (n=16), CIN3 covering 3-4 quadrants (n=14) and randomly selected CIN3 (n=41). FAM19A4/miR124-2 methylation analysis was performed blinded on first diagnosis.
RESULTS
– All pregnant women with cervical cancer and with CIN3 progressing to cancer tested positive for FAM19A4/miR124-2 methylation (100%, 22/22).
– In the regressing CIN3 group 47.5% and in the group without CIN 21.6% tested methylation positive.
– High-volume CIN3 and random selected CIN3 were methylation-positive in 91.7% and 82.1%.
– Methylation levels were significantly higher in progressive CIN3 and cancer compared to the controls.
– The likelihood ratio of a negative methylation test (LR-) for progressive CIN3+ was 0.
CONCLUSIONS
• A negative FAM19A4/miR124-2 methylation test can rule out progressive CIN disease in pregnant women diagnosed with CIN3.
• This can help the clinician by managing these pregnant women with conservative follow-up until after delivery.
