UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010843 |
|---|---|
| Receipt number | R000012696 |
| Scientific Title | Randomized controlled trial to evaluate the efficacy of concurrent liquid-based cytology (LBC) and HPV DNA testing versus LBC alone for the primary cervical cancer screening |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2015/12/24 18:54:25 |
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Basic information
Public title
Randomized controlled trial to evaluate the efficacy of concurrent liquid-based cytology (LBC) and HPV DNA testing versus LBC alone for the primary cervical cancer screening
Acronym
Cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening (CITRUS study)
Scientific Title
Randomized controlled trial to evaluate the efficacy of concurrent liquid-based cytology (LBC) and HPV DNA testing versus LBC alone for the primary cervical cancer screening
Scientific Title:Acronym
Cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening (CITRUS study)
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess efficacy of the screening with concurrent liquid-based cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of CIN3 or worse during whole periods
Key secondary outcomes
1) The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline
2) The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline
3) The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline
4) The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline
5) The number of cervical cytology performance
6) The number of colposcopy and biopsy performance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Cervical cancer screening by using liquid based cytology as a standard screening modality
Interventions/Control_2
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentary screening modality
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women aged 30-64 years old.
2) Participants provided written informed consent.
Key exclusion criteria
1) Women who will receive planed HPV DNA testing by local governmental cervical cancer program next six years.
2) Women who have had cervical invasive cancer before.
3) Women who have underwent cervical conization.
4) Women who have underwent hysterectomy.
5) Women who have had or have the cytological abnormalities and are under follow-up.
6) Pregnant women.
7) Women judged ineligible for this trial by physician.
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Aoki |
Organization
School of Medicine, Keio University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
TEL
03-3353-1211(62391)
aoki@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Aoki |
Organization
School of Medicine, Keio University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
TEL
03-3353-1211(62391)
Homepage URL
aoki@z7.keio.jp
Sponsor or person
Institute
The Japanese Society of Clinical Cytology
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Clinical Cytology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
本研究に協力している41カ所（山梨県）および19カ所（千葉県柏市）の検診実施施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 01 | Day |
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 30 | Day |
Last modified on
| 2015 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012696
