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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016839 |
Receipt No. | R000019549 |
Scientific Title | Exploratory study for concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis from liquid based cytology. |
Date of disclosure of the study information | 2015/03/25 |
Last modified on | 2016/03/22 |
Basic information | ||
Public title | Exploratory study for concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis from liquid based cytology. | |
Acronym | Concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis. | |
Scientific Title | Exploratory study for concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis from liquid based cytology. | |
Scientific Title:Acronym | Concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis. | |
Region |
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Condition | ||
Condition | Cervical cytology, Sexual transmitted Infection | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the possible association between cervical cytology, high-risk HPV and Chlamydia trachomatis. |
Basic objectives2 | Others |
Basic objectives -Others | association |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Association between cervical cytology results and Chlamydia trachomatis and association between high-risk HPV and Chlamydia trachomatis. |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Woman aged 20 years or older
Woman whom underwent a cervical cancer screening Woman whom underwent a sexually transmitted infection screening |
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Key exclusion criteria | Woman who is pregnant
Woman who has a risk for taking a specimen Woman who has difficulty to get the informed consent Woman whom the investigator judged as inappropriate as a subject of this study |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Aichi Medical University Hospital | ||||||
Division name | Department Of Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 1-1, Yazakokarimata, Nagakute,Aichi | ||||||
TEL | 0561-62-3311 | ||||||
yasuyuki@aichi-med-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nippon Becton Dickinson Company, Ltd | ||||||
Division name | Medical Affairs | ||||||
Zip code | |||||||
Address | 15-1,Akasaka 4-chome,Minato-ku,Tokyo | ||||||
TEL | 03-6234-5628 | ||||||
Homepage URL | |||||||
shusaku_tozaka@bd.com |
Sponsor | |
Institute | Aichi Medical University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Nippon Becton Dickinson Company, Ltd |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Hoshina clinic
Tsushima ruriko women's life science clinic Ginza Ihc Omotesando |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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Other | |
Other related information | Both high-risk HPV and Chlamydia trachomatis are sexual transmitted infection. If association of cervical cytology results, Chlamydia trachomatis infection and high-risk HPV are shown, significance of concurrent testing may be found. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019549 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |