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DNA Methylation Biomarkers for Cervical Cancer Screening

DNA Methylation Biomarkers for Cervical Cancer Screening

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02605941
Enrollment
5000
Registered
2015-11-17
Start date
2014-02-28
Completion date
2016-08-31
Last updated
2015-11-17

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

Conditions

Cervical Cancer, Cervical Intraepithelial Neoplasia

Keywords

DNA methylation, Cervical cancer

Brief summary

The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.

Interventions

None listed

Sponsors

Mackay Memorial Hospital
CollaboratorOTHER
Li Shin Hospital
CollaboratorOTHER
Chang Gung Memorial Hospital
CollaboratorOTHER
iStat Biomedical CO., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* women with age ≥20 and sexual experience * Agree to sign ICF

Exclusion criteria

* women had received Hysterectomy * women had destructive therapy for cervical lesions in 6 months, for examples: conization, Laser or cryotherapy, chemotherapy, and radiation therapy * Women are at pregnancy or had baby delivery in 6 weeks

Design outcomes

Primary

MeasureTime frameDescription
Performance of DNA methylation in identification of CIN3 or worse.3 yearsPatient's information, including clinical diagnosis and the molecular testing results etc., will be collected. Performances of the screening tools will be compared.

Countries

Taiwan

Contacts

Primary ContactChien-Ping Hung
apple@istatbio.com+886-2-2696-3518
Backup ContactHsiu-yuan Tsao
hytsao@istatbio.com+886-2-2696-3518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026