Cervical Cancer Clinical Trial
Official title:
DNA Methylation Biomarkers for Cervical Cancer Screening
The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.
| Status | Recruiting |
| Enrollment | 5000 |
| Est. completion date | August 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Mackay Memorial Hospital, Linkou Chang Gung Memorial Hospital, Lin-Shin Medical Corporation Lin-Shin Hosptial | Taipei, Taoyuan, and Taichung |
| Lead Sponsor | Collaborator |
|---|---|
| iStat Biomedical CO., Ltd. | Chang Gung Memorial Hospital, Li Shin Hospital, Mackay Memorial Hospital |
Taiwan,
Chao TK, Ke FY, Liao YP, Wang HC, Yu CP, Lai HC. Triage of cervical cytological diagnoses of atypical squamous cells by DNA methylation of paired boxed gene 1 (PAX1). Diagn Cytopathol. 2013 Jan;41(1):41-6. doi: 10.1002/dc.21758. Epub 2011 Jun 27. — View Citation
Huang TH, Lai HC, Liu HW, Lin CJ, Wang KH, Ding DC, Chu TY. Quantitative analysis of methylation status of the PAX1 gene for detection of cervical cancer. Int J Gynecol Cancer. 2010 May;20(4):513-9. doi: 10.1111/IGC.0b013e3181c7fe6e. — View Citation
Krane JF, Granter SR, Trask CE, Hogan CL, Lee KR. Papanicolaou smear sensitivity for the detection of adenocarcinoma of the cervix: a study of 49 cases. Cancer. 2001 Feb 25;93(1):8-15. — View Citation
Lai HC, Lin YW, Huang RL, Chung MT, Wang HC, Liao YP, Su PH, Liu YL, Yu MH. Quantitative DNA methylation analysis detects cervical intraepithelial neoplasms type 3 and worse. Cancer. 2010 Sep 15;116(18):4266-74. doi: 10.1002/cncr.25252. — View Citation
Lai HC, Lin YW, Huang TH, Yan P, Huang RL, Wang HC, Liu J, Chan MW, Chu TY, Sun CA, Chang CC, Yu MH. Identification of novel DNA methylation markers in cervical cancer. Int J Cancer. 2008 Jul 1;123(1):161-7. doi: 10.1002/ijc.23519. — View Citation
Sova P, Feng Q, Geiss G, Wood T, Strauss R, Rudolf V, Lieber A, Kiviat N. Discovery of novel methylation biomarkers in cervical carcinoma by global demethylation and microarray analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):114-23. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Performance of DNA methylation in identification of CIN3 or worse. | Patient's information, including clinical diagnosis and the molecular testing results etc., will be collected. Performances of the screening tools will be compared. | 3 years | No |
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