Cervical CancerPhase 4NCT01895517
CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening （CITRUS Study）
A Phase 4 study testing LBC and LBC plus HPV DNA testing in people with Cervical Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- LBC and LBC plus HPV DNA testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,471 participants
- Where
- 1 siteJapan
- Study dates
- 7 Jun 2013to 31 May 2023
- Phase
- Phase 4
- 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 30 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 30-64 years old
- Participants provided written informed consent
Who cannot join
- Women who
- will receive planed HPV DNA testing by local governmental cervical cancer program next six years
- have had cervical invasive cancer before
- have undergone cervical conization
- have undergone hysterectomy
- have had or have the cytological abnormalities and are under follow-up
- are pregnant
- are judged ineligible for this trial by physician
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Cervical Cancer
- Being tested
- LBC, LBC plus HPV DNA testing
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBCOther
Cervical cancer screening by using liquid based cytology as a standard screening modality
LBC plus HPV DNA testingOther
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
| Study group | Role | What they receive |
|---|---|---|
| LBC | Active comparator | Cervical cancer screening by using liquid based cytology as a standard screening modality Receives: Other: LBC |
| LBC plus HPV DNA testing | Experimental | Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality Receives: Other: LBC plus HPV DNA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
Measured: 6 years
Secondary outcomes (6)
The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline
Measured: 2 years, 4 years, 6 years
The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline
Measured: 2 years, 4 years, 6 years
The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline
Measured: 2 years, 4 years, 6 years
The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline
Measured: 2 years, 4 years, 6 years
The number of cervical cytology performance
Measured: 6 years
The number of colposcopy and biopsy performance
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study start7 Jun 2013
- Primary completion30 Nov 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Keio University, Jikei University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895517
- Sponsor's protocol ID
- TRIUC1312
- Other IDs
- UMIN000010843
- Status last verified
- May 2022
- First submitted
- 4 Jul 2013
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Morisada T, Teramoto K, Takano H, Sakamoto I, Nishio H, Iwata T, Hashi A, Katoh R, Okamoto A, Sasaki H, Nakatani E, Teramukai S, Aoki D. CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18,471 women. Cancer Epidemiol. 2017 Oct;50(Pt A):60-67. doi: 10.1016/j.canep.2017.07.017. Epub 2017 Aug 16.
PubMed 28818742
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01895517
- Acronym / sponsor ID
- TRIUC1312
- Conditions
- Cervical Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,471 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Keio University, Jikei University School of Medicine
- Study start
- 7 Jun 2013 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Jul 2013 (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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBC | Active comparator | Other: LBCCervical cancer screening by using liquid based cytology as a standard screening modality |
| LBC plus HPV DNA testing | Experimental | Other: LBC plus HPV DNA testingCervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 30-64 years old
- Participants provided written informed consent
Key exclusion criteria (8 listed)
- Women who
- will receive planed HPV DNA testing by local governmental cervical cancer program next six years
- have had cervical invasive cancer before
- have undergone cervical conization
- have undergone hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBCCervical cancer screening by using liquid based cytology as a standard screening modality | Other | LBC |
| LBC plus HPV DNA testingCervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality | Other | LBC plus HPV DNA testing |
Primary outcome
The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
Time frame: 6 years
6 secondary outcomes
The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline
Time frame: 2 years, 4 years, 6 years
The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline
Time frame: 2 years, 4 years, 6 years
The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline
Time frame: 2 years, 4 years, 6 years
The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline
Time frame: 2 years, 4 years, 6 years
The number of cervical cytology performance
Time frame: 6 years
The number of colposcopy and biopsy performance
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 28818742Morisada T, Teramoto K, Takano H, Sakamoto I, Nishio H, Iwata T, Hashi A, Katoh R, Okamoto A, Sasaki H, Nakatani E, Teramukai S, Aoki D. CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18,471 women. Cancer Epidemiol. 2017 Oct;50(Pt A):60-67. doi: 10.1016/j.canep.2017.07.017. Epub 2017 Aug 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LBC and LBC plus HPV DNA testing in people with Cervical Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
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 8 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: finished, as of the sponsor's last update on 26 Jun 2023. 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 Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period (time frame: 6 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 NCT01895517, which also lists 1 linked publication.
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 26 Jun 2023.