Cervical CancerEarly Phase 1APACHE-2NCT01588301
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
A Early Phase 1 study testing Attending for cervical cytology and Kit for Self-collected vaginal sample in people with Cervical Cancer and Human Papillomavirus Infection, run by University Hospital, Tours.
Trial summary
Scientific Context: High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Human Papillomavirus Infection
- What is being tested?
- Attending for cervical cytology and Kit for Self-collected vaginal sample
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,998 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2012
- Phase
- Early Phase 1
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women from 30 to 65 years
- Living in Indre-et-Loire (french territorial division 37)
Who cannot join
- Women who attend organized cervical cancer screening or who answer to the invitation
- Cervical smear made in the three last years
- HPV linked cervical condition undergoing treatment
- Hysterectomy (including cervix)
About this study
Official title: Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample
Scientific Context:
High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.
Read more
The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home.
Description of the project :
Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:
- Intervention arm 1:
Women will receive a further invitation to make a cervical smear
- Intervention arm 2:
Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV).
For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.
- Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.
- Conditions
- Cervical Cancer, Human Papillomavirus Infection
- Being tested
- Attending for cervical cytology, Kit for Self-collected vaginal sample
- Keywords
- Cervical Cancer Screening, Human Papillomavirus (HPV), Self-collected vaginal sample, Cervical Smear
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attending for cervical cytologyBehavioural
A further invitation to attend for cervical cytology are going to be sent by mail to women
Kit for Self-collected vaginal sampleBehavioural
Kit for self-collected vaginal sample are going to be directly sent at women's home
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Further invitation by mail | Experimental | Further invitation to attend for cervical cytology Receives: Behavioral: Attending for cervical cytology |
| Group 2 : Kit for Self-collected vaginal sample | Experimental | Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV) Receives: Behavioral: Kit for Self-collected vaginal sample |
| Group 3: Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of women's attitude according to the arm: participation or not to a whole screening action
Comparison of attitudes among women not attending organized cervical cancer according to the type of intervention or the lack of intervention: participation or not to a whole screening action.
Are considered as whole screening action:
- cervical smear
- HPV DNA testing on self-collected vaginal sample negative (no infection by a high-risk HPV)
- HPV DNA testing on self-collected vaginal sample positive (infection by a high-risk HPV) followed by a cervical smear
Measured: 9 months after the beginning of the study (sending of mails)
Secondary outcomes (2)
Analysis in sub-groups
Analysis in sub-groups in order to compare the efficacy of interventions according to :
- The age
- Health insurance system
- Distribution map (urban area, peri-urban area, rural area)
Measured: 9 months after the beginning of the study (sending of mails)
Identification of the psychological determinants and mechanisms (checks and motivational factors)
Identify the psychological determinants and mechanisms (checks and motivational factors) that can affect enrollment to the screening procedure for self-collection vaginal sample or cervical smear.
Nine months after the beginning of the study, a questionnaire will be send to the 6000 women.
Measured: 9 months after the beginning of the study (sending of mails)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,998 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken HAGUENOER, Study director, François Rabelais University, Public Health Laboratory, Tours, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588301
- Sponsor's protocol ID
- INCA08-KH / APACHE-2
- Acronym
- APACHE-2
- Status last verified
- Jul 2014
- First submitted
- 12 Mar 2012
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample
- ClinicalTrials.gov ID
- NCT01588301
- Acronym / sponsor ID
- APACHE-2 / INCA08-KH / APACHE-2
- Conditions
- Cervical Cancer, Human Papillomavirus Infection
- Keywords
- Cervical Cancer Screening, Human Papillomavirus (HPV), Self-collected vaginal sample, Cervical Smear
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,998 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Apr 2012 (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.
Scientific Context:
High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.
The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home.
Description of the project :
Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:
- Intervention arm 1:
Women will receive a further invitation to make a cervical smear
- Intervention arm 2:
Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV).
For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.
- Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Further invitation by mail | Experimental | Behavioral: Attending for cervical cytologyFurther invitation to attend for cervical cytology |
| Group 2 : Kit for Self-collected vaginal sample | Experimental | Behavioral: Kit for Self-collected vaginal sampleKit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV) |
| Group 3: Control | No intervention | – |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women from 30 to 65 years
- Living in Indre-et-Loire (french territorial division 37)
Key exclusion criteria (4 listed)
- Women who attend organized cervical cancer screening or who answer to the invitation
- Cervical smear made in the three last years
- HPV linked cervical condition undergoing treatment
- Hysterectomy (including cervix)
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 |
|---|---|---|
| Attending for cervical cytologyA further invitation to attend for cervical cytology are going to be sent by mail to women | Behavioural | Group 1 : Further invitation by mail |
| Kit for Self-collected vaginal sampleKit for self-collected vaginal sample are going to be directly sent at women's home | Behavioural | Group 2 : Kit for Self-collected vaginal sample |
Primary outcome
Comparison of women's attitude according to the arm: participation or not to a whole screening action
Time frame: 9 months after the beginning of the study (sending of mails)
Comparison of attitudes among women not attending organized cervical cancer according to the type of intervention or the lack of intervention: participation or not to a whole screening action. Are considered as whole screening action: * cervical smear * HPV DNA testing on self-collected vaginal sample negative (no infection by a high-risk HPV) * HPV DNA testing on self-collected vaginal sample positive (infection by a high-risk HPV) followed by a cervical smear
2 secondary outcomes
Analysis in sub-groups
Time frame: 9 months after the beginning of the study (sending of mails)
Identification of the psychological determinants and mechanisms (checks and motivational factors)
Time frame: 9 months after the beginning of the study (sending of mails)
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 12 Sep 2014.
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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.
Ken HAGUENOER study director
François Rabelais University, Public Health Laboratory, Tours, France
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Attending for cervical cytology and Kit for Self-collected vaginal sample in people with Cervical Cancer and Human Papillomavirus Infection, run by University Hospital, Tours.
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 4 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Comparison of women's attitude according to the arm: participation or not to a whole screening action (time frame: 9 months after the beginning of the study (sending of mails)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2014.