Cervical Intraepithelial NeoplasiaNCT02605941
DNA Methylation Biomarkers for Cervical Cancer Screening
An observational study of Cervical Intraepithelial Neoplasia and Cervical Cancer, run by iStat Biomedical CO., Ltd. at 1 site in Taiwan.
Trial summary
The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervical Cancer
- How many people
- 5,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- women with age ≥20 and sexual experience
- Agree to sign ICF
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memorial Hospital, Linkou Chang Gung Memorial Hospital, Lin-Shin Medical Corporation Lin-Shin Hosptial
Taipei, Taoyuan, and Taichung
Yuh-cheng Yang, MD
Shih-chu Ho, MD
About this study
The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.
- Keywords
- DNA methylation, Cervical cancer
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startFeb 2014
- Primary completionDec 2015 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iStat Biomedical CO., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mackay Memorial Hospital, Li Shin Hospital, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Yuh-cheng Yang, MD, Study chair, Mackay Memorial HospitalShih-chu Ho, MD, Principal investigator, Li Shin HospitalTing-Chang Chang, MD., MPH., Principal investigator, Chang Gung Memorial HospitalChih-Long Chang, MD, Ph.D., Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605941
- Sponsor's protocol ID
- epigene-13151
- Status last verified
- Nov 2015
- First submitted
- 6 Nov 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16434596Lai 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.
PubMed 18398837Huang 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.
PubMed 20442585Lai 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.
PubMed 20564139Chao 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.
PubMed 21710649Krane 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.
PubMed 11241260
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation Biomarkers for Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT02605941
- Acronym / sponsor ID
- epigene-13151
- Keywords
- DNA methylation, Cervical cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- iStat Biomedical CO., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Mackay Memorial Hospital, Li Shin Hospital, Chang Gung Memorial Hospital
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- women with age ≥20 and sexual experience
- Agree to sign ICF
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of DNA methylation in identification of CIN3 or worse.
Time frame: 3 years
Patient's information, including clinical diagnosis and the molecular testing results etc., will be collected. Performances of the screening tools will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Background: PubMed 16434596Sova 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.
- Background: PubMed 18398837Lai 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.
- Background: PubMed 20442585Huang 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.
- Background: PubMed 20564139Lai 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.
- Background: PubMed 21710649Chao 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.
- Background: PubMed 11241260Krane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuh-cheng Yang, MD study chair
Mackay Memorial Hospital
Shih-chu Ho, MD principal investigator
Li Shin Hospital
Ting-Chang Chang, MD., MPH. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia and Cervical Cancer, run by iStat Biomedical CO., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Ping Hung (+886-2-2696-3518 ext. 15, apple@istatbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of DNA methylation in identification of CIN3 or worse. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605941, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.