Clinical trial NCT02605941: DNA Methylation Biomarkers for Cervical Cancer Screening
Official title: DNA Methylation Biomarkers for Cervical Cancer Screening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Intraepithelial Neoplasia
Cervical Cancer
Keywords: DNA methylation
Cervical cancer
Lead sponsor: iStat Biomedical CO., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Mackay Memorial Hospital
name: Li Shin Hospital
name: Chang Gung Memorial Hospital
First posted: 2015-11-17
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators plan to recruit 5,000 women to participate this study in Taiwan. Papanicolaou test, high-risk HPV typing and DNA methylation will be co-tested. It is expected to find an optimal solution for molecular cervical cancer screening. The participant will be recruited by Mackay Memorial Hospital, Chang Gung Memorial Hospital, and Lin-Hsin Hospital.

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


Eligibility criteria: 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

Primary outcomes:
measure: Performance of DNA methylation in identification of CIN3 or worse.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taoyuan, and Taichung
country: Taiwan
facility: Mackay Memorial Hospital, Linkou Chang Gung Memorial Hospital, Lin-Shin Medical Corporation Lin-Shin Hosptial
Study officials:
affiliation: Mackay Memorial Hospital
name: Yuh-cheng Yang, MD
role: STUDY_CHAIR
affiliation: Li Shin Hospital
name: Shih-chu Ho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Ting-Chang Chang, MD., MPH.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mackay Memorial Hospital
name: Chih-Long Chang, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1158/1055-9965.EPI-05-0323.
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.
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.
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.
citation: 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.
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.