NCT02605941

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

November 6, 2015

Last Update Submit

November 12, 2015

Conditions

Cervical Intraepithelial NeoplasiaCervical Cancer

Keywords

DNA methylationCervical cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital, Linkou Chang Gung Memorial Hospital, Lin-Shin Medical Corporation Lin-Shin Hosptial

Taipei, Taoyuan, and Taichung, Taiwan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 16434596BACKGROUND

  • 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.

    PMID: 18398837BACKGROUND

  • 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.

    PMID: 20442585BACKGROUND

  • 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.

    PMID: 20564139BACKGROUND

  • 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.

    PMID: 21710649BACKGROUND

  • 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.

    PMID: 11241260BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

cervical cells

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Study Officials

  • Yuh-cheng Yang, MD

    Mackay Memorial Hospital

    STUDY CHAIR

  • Shih-chu Ho, MD

    Li Shin Hospital

    PRINCIPAL INVESTIGATOR

  • Ting-Chang Chang, MD., MPH.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Chih-Long Chang, MD, Ph.D.

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Ping Hung

CONTACT

+886-2-2696-3518apple@istatbio.com

Hsiu-yuan Tsao

CONTACT

+886-2-2696-3518hytsao@istatbio.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 17, 2015

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

TW(1)