Evaluation of the PreCursor-M+® in CIN2
Recruiting
Observational Study
Cervical Intraepithelial Neoplasia Grade 2
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 100 (estimated)
- Sponsor
- European Institute of Oncology · Other
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About This Trial
The goal of this observational study is to to evaluate the accuracy and sensitivity of PreCursor-M+ on a post-aliquot of liquid-based cytology (LBC) cervical samples (biopsy) obtained by physicians in a group of women with histologically-proven diagnoses of CIN2.
The PreCursor-M+® assay is a multiplex real-time methylation specific PCR test that identifies the level of promotor methylation of the…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. age at diagnosis of 18 years or older;
2. histological confirmation of CIN2 after colposcopic-guided cervical biopsy or conservative surgical treatment, including loop electrosurgical excision procedure (LEEP) and laser conization;
3. known HPV test result at baseline;
4. abi…
Contacts