HPV-Related Cervical CarcinomaNCT05314907
Acceptability of Self-sampling for Cervical Cancer Screening
A study testing Explanation on how to use self-sampling device and training in the screening visit. and Only explanation on how to use self-sampling device. in people with HPV-Related Cervical Carcinoma and Self-sampling, run by Institut d'Investigació Biomèdica de Bellvitge at 3 sites in Spain.
Trial summary
Main objectives: 1.1. To evaluate the use of self-sampling for HPV test in regular attendants of cervical cancer screening as a primary sample collection method. 1.2. To assess the impact on the acceptability of an educational intervention. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- HPV-Related Cervical Carcinoma, Self-sampling, Cervical Cancer Screening
- What is being tested?
- Explanation on how to use self-sampling device and training in the screening visit. and Only explanation on how to use self-sampling device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,614 participants
- Where
- 3 sitesSpain
- Study dates
- 28 Nov 2018to Jun 2022
- Phase
- Interventional
- 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 aged 30 to 65 years (both inclusive) with a adequate prior history of cervical cancer screening (last cytological screening test no more than four years ago).
Who cannot join
- Women under 30 years of age.
- Women over 65 years of age.
- Pregnant women.
- Women with hysterectomy.
- Women between 30 and 65 years of age who underwent the last screening test more than four years ago.
- Women between the ages of 30 and 65 who attend for follow-up of some ongoing cervical pathology.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 1 recruiting
- Active, not recruiting
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
- Recruiting
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Canary Islands, 35016
Miguel Andujar, Dr., +34928308666, mandsan@gobiernodecanarias.org
Miguel Andujar, Dr.
- Completed
CAP II Cerdanyola-Ripollet - Institut Català de la Salut
Ripollet, Barcelona, 08291
About this study
Official title: Acceptability, Optimization and Cost-effectiveness for Self-sampling Cervical Cancer Screening.
Main objectives:
1.1. To evaluate the use of self-sampling for HPV test in regular attendants of cervical cancer screening as a primary sample collection method.
Read more
1.2. To assess the impact on the acceptability of an educational intervention. 1.3 Confirm the concordance of HPV detection in the samples collected by the professional and in self-sampling.
Project methodology:
Randomized, parallel multicenter clinical trial in women aged 30-65 years regularly attending cervical cancer screening residents in the Autonomous Communities of Catalonia and the Canary Islands (Spain). The woman attends the routine screening visit where the health professional collects a sample from the cervical screening. She then offers her the study and if the woman accepts, she offers her the SS as a screening test. The modality of information and practice of the self-sampling is random:
- Training group): Educational intervention with self-sampling practice: clinician-led explanation on how to proceed with self-sampling prior to collecting a self-sample at the clinic.
- No prior trainning group): Same training without practicing self-sampling collection.
Both groups has a standard of care cervical sample collection by a clinician. Women are asked to return a self-sampling specimen one month after the baseline visit together with an acceptability questionnaire on self-sampling use.
Acceptability will be analyzed according to two definitions:
- proportion of women who returned the self-sampling device,
- proportion of women who report wanting to use self-sampling in future screens in the acceptability questionnaire.
HPV agreement between collection methods will be calculated using Cohen's Kappa coefficient. Cost-effectiveness analisis will be done on public health system by a mathematical model of the cervical cancer natural history and HPV, adjusted for data in Spain.
Self-sampling device uses in this trial is Evalyn Brush from Rovers and the HPV detection is COBAS 4800 from Roche.
Read the detailed description
Women aged 30-65 years regular user of cervical cancer screening, not pregnant and with no history of cervical disease are recruited at the cervical cancer screening clinics.
Women are recruited in two Spanish distant areas, Catalonia with participant clinics in Cerdanyola del Vallés, Barberà del Vallés, Ripollet, Badia del Vallés and Sabadell, and the Canary Islands, including the clinics of Arucas, Gáldar, Prudencio Guzmán, Telde, Vecindario, Maspalomas. In both areas the cervical cancer screening was free of charge, opportunistic with cytology as primary test.
Women who agreed to participate in the study signs an informed consent and are provided with a short questionnaire including sociodemographic and screening history information.
Women are randomised, as they came to the screening visit, in two groups:
- Training group: The trained provider shows the woman how to use the self-sampling device and asks her to collect her self-sample immediately after, at the health centre. Then, the provider gives her a new device to take a new sample at home and send it back to the health center in a month time.
- No prior training group: The health provider shows the woman how to use self-sampling device and gives the woman a device for her to take a sample at home in a month interval and send it back to the health center.
Before the process of self-sampling, women proceed with the clinical regular screening visit. The professional collects a liquid based cervical sample. An aliquot of the sample is used for cervical cytology (screening sample) and aliquot for HPV detection (study professional sample) using the Cobas system drom Roche
The provider uses the clinical visit to explain the self-sampling process. Afterwards women in training group proceed to take her vaginal sample. In both groups a cervibrush is given for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, women are requested to return the self-collected sample together with the questionnaire in person to the recruitment centre (acceptability questionnaire).
Information available for each women includes date of birth, nationality, country of birth, educational level, marital status, work, family responsibilities and data on their previous history of cervical cancer screening as if they ever did a cytology, the result of the last cytology and number of screening tests lifetime (sociodemographic questionnaire). Also, among the women who collects the self-sampling there was available information about questions on acceptability and practicalities of sampling procedures (acceptability questionnaire).
The project was approved by the ethical committees of the Bellvitge University Hospital (number PR223/17), IDIAP Jordi Gol (number P18/099) and Maternal and Child Insular University Hospital Complex (number 2018-178-1). Any information regarding the identification of patients is anonymized before analysis.
The self-sample is collected using the Rovers Medical Devices Evalyn Brush from Rovers.
Detection of HPV of all the samples from Catalonia is carried out at the Infections and Cancer laboratory of the Catalan Institute of Oncology in Barcelona, while those from the Canary Islands is processed in the Pathological Anatomy Service of the Maternal and Child Insular University Hospital Complex of Las Palmas de Gran Canaria.
All the samples are processed using Cobas HPV test Roche Cobas 4800 HPV test. Cobas HPV test is an in-vitro quantitative detection technique for high-risk HPV DNA by polymerase chain reaction (PCR) amplification and can detect a total of 14 HR-HPV subtypes and provides the results of HPV 16 and HPV 18, and the pooled results of the other 12 subtypes in the assay.
Data from both sociodemographic and acceptability questionnaires and test results (clinical and self-sampling) are collected using Research Electronic Data Capture call REDCap tools hosted at Catalan Institute of Oncology. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources. Personal involved in the project had access to the REDCap platform through a username and password and enter data of each woman who has been anonymized.
- Being tested
- Explanation on how to use self-sampling device and training in the screening visit., Only explanation on how to use self-sampling device.
- Keywords
- Self-sampling, HPV, Cervical cancer screening, Acceptability, HPV concordance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explanation on how to use self-sampling device and training in the screening visit.Device
Also called Evalyn Brush
During the screening visit, woman is offered to participate in the study. If she accepts, informed consent is signed, a sociodemographic questionnaire is collected, and a cervical sample is collected for HPV detection by the health professional in the consultation.
Then, the professional informs the woman of how to carry out the self-collection using Evalyn Brush and after the woman collects an HPV sample by self-sampling in the same medical center as a trainning.
Finally, a new cervibrush (Evalyn brush) is given to the woman for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, woman is requested to return the self-collected sample together with the questionnaire in person to the recruitment centre.
Only explanation on how to use self-sampling device.Other
During the screening visit, woman is offered to participate in the study. If she accepts, informed consent is signed, a sociodemographic questionnaire is collected, and a cervical sample is taken for HPV detection by the health professional in the consultation.
Then, the professional informs the woman of how to carry out the self-collection using Evalyn.
Finally, a Evalyn brush is given to the woman for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, woman is requested to return the self-collected sample together with the questionnaire in person to the recruitment centre.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Active comparator | The Health professional shows the woman how to use the self-sampling device (Evalyn Brush) and then she collects a self-sample at the health centre as a training. Receives: Device: Explanation on how to use self-sampling device and training in the screening visit. |
| No prior training group | Placebo comparator | The Health professional shows the woman how to use the self-sampling device (Evalyn Brush). Receives: Other: Only explanation on how to use self-sampling device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-sampling acceptability for cervical cancer screening
Acceptability will be compared by study arm and evaluated as 1) proportion of women that return the self-sampling device, 2) proportion of women that return the self-sampling device and respond to favour future screening with self-sampling. This will be evaluated according to the sociodemographic variables of the participants and the results of the acceptability questionnaire that each woman has filled out.
Measured: 2 months
Secondary outcomes (2)
The cost-effectiveness of cervical Self-Sampling on public health system in Spain
A simulation model will be built based on the natural history of HPV and cervical cancer calibrated to data from Spain in reference to age-specific cervical cancer incidence and HPV prevalence. Different strategies will be evaluated that will vary according to some relevant parameters such as age and frequency of screening, self-sampling at the health center or at home. For each of the strategies, health outcomes and costs will be obtained that will allow us to calculate the reduction in lifetime cancer risk, the quality-adjusted life years (QALYs) or the cost per lifetime. Finally a cost-effectiveness analysis will be carried out between the different strategies compared to the current situation. For doing this, incremental cost-effectiveness ratios will be calculated, expressed in € per QALY gained. Finally, the impact that applying the most cost-effective interventions would have on the public health budget will be evaluated.
Measured: This is a mathematical and cost analisis. No participants are assessed (time frame 2 years)
HPV test agreement between self-sampling and clinician-collected samples
A Kappa index with 95% confidence interval will be performed to observe the concordance between the HPV results from self-sampling compared to HPV results from clinical samples. A description of positivity prevalence will be also provided and the ratio of HPV positivity and the agreement (in %) between the self-sample and clinical samples will be calculated.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start28 Nov 2018
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HPV-Related Cervical CarcinomaStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario Insular Materno Infantil, Institut Català de la Salut, Institut Català d'Oncologia
- Responsible party
- Principal investigator, Raquel Ibáñez, Institut d'Investigació Biomèdica de Bellvitge
- Investigators
- Raquel Ibáñez Pérez, Dra., Principal investigator, Institut Català d'Oncologia - IDIBELLSilvia de Sanjosé Llongueras, Dra., Study director, National Cancer Institute (NCI)Amelia Acera, Dra., Study chair, Institut Català de la SalutMiguel Andujar, Dr., Principal investigator, Complejo Hospitalario Universitario Insular Materno Infantil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314907
- Sponsor's protocol ID
- PI17/01179
- Other IDs
- PI17/01456, PI17/01179
- Status last verified
- Apr 2022
- First submitted
- 19 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serrano B, Ibanez R, Robles C, Peremiquel-Trillas P, de Sanjose S, Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening. Prev Med. 2022 Jan;154:106900. doi: 10.1016/j.ypmed.2021.106900. Epub 2021 Nov 30.
PubMed 34861338Ibanez R, Roura E, Acera A, Andujar M, Pavon MA, Bruni L, de Sanjose S. HPV self-sampling among cervical cancer screening users in Spain: A randomized clinical trial of on-site training to increase the acceptability. Prev Med. 2023 Aug;173:107571. doi: 10.1016/j.ypmed.2023.107571. Epub 2023 Jun 10.
PubMed 37308042
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Optimization and Cost-effectiveness for Self-sampling Cervical Cancer Screening.
- ClinicalTrials.gov ID
- NCT05314907
- Acronym / sponsor ID
- PI17/01179
- Keywords
- Self-sampling, HPV, Cervical cancer screening, Acceptability, HPV concordance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,614 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de BellvitgeUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario Insular Materno Infantil, Institut Català de la Salut, Institut Català d'Oncologia
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 7 Apr 2022 (actual)
- 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.
Main objectives:
1.1. To evaluate the use of self-sampling for HPV test in regular attendants of cervical cancer screening as a primary sample collection method.
1.2. To assess the impact on the acceptability of an educational intervention. 1.3 Confirm the concordance of HPV detection in the samples collected by the professional and in self-sampling.
Project methodology:
Randomized, parallel multicenter clinical trial in women aged 30-65 years regularly attending cervical cancer screening residents in the Autonomous Communities of Catalonia and the Canary Islands (Spain). The woman attends the routine screening visit where the health professional collects a sample from the cervical screening. She then offers her the study and if the woman accepts, she offers her the SS as a screening test. The modality of information and practice of the self-sampling is random:
- Training group): Educational intervention with self-sampling practice: clinician-led explanation on how to proceed with self-sampling prior to collecting a self-sample at the clinic.
- No prior trainning group): Same training without practicing self-sampling collection.
Both groups has a standard of care cervical sample collection by a clinician. Women are asked to return a self-sampling specimen one month after the baseline visit together with an acceptability questionnaire on self-sampling use.
Acceptability will be analyzed according to two definitions:
- proportion of women who returned the self-sampling device,
- proportion of women who report wanting to use self-sampling in future screens in the acceptability questionnaire.
HPV agreement between collection methods will be calculated using Cohen's Kappa coefficient. Cost-effectiveness analisis will be done on public health system by a mathematical model of the cervical cancer natural history and HPV, adjusted for data in Spain.
Self-sampling device uses in this trial is Evalyn Brush from Rovers and the HPV detection is COBAS 4800 from Roche.
Detailed description
Women aged 30-65 years regular user of cervical cancer screening, not pregnant and with no history of cervical disease are recruited at the cervical cancer screening clinics.
Women are recruited in two Spanish distant areas, Catalonia with participant clinics in Cerdanyola del Vallés, Barberà del Vallés, Ripollet, Badia del Vallés and Sabadell, and the Canary Islands, including the clinics of Arucas, Gáldar, Prudencio Guzmán, Telde, Vecindario, Maspalomas. In both areas the cervical cancer screening was free of charge, opportunistic with cytology as primary test.
Women who agreed to participate in the study signs an informed consent and are provided with a short questionnaire including sociodemographic and screening history information.
Women are randomised, as they came to the screening visit, in two groups:
- Training group: The trained provider shows the woman how to use the self-sampling device and asks her to collect her self-sample immediately after, at the health centre. Then, the provider gives her a new device to take a new sample at home and send it back to the health center in a month time.
- No prior training group: The health provider shows the woman how to use self-sampling device and gives the woman a device for her to take a sample at home in a month interval and send it back to the health center.
Before the process of self-sampling, women proceed with the clinical regular screening visit. The professional collects a liquid based cervical sample. An aliquot of the sample is used for cervical cytology (screening sample) and aliquot for HPV detection (study professional sample) using the Cobas system drom Roche
The provider uses the clinical visit to explain the self-sampling process. Afterwards women in training group proceed to take her vaginal sample. In both groups a cervibrush is given for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, women are requested to return the self-collected sample together with the questionnaire in person to the recruitment centre (acceptability questionnaire).
Information available for each women includes date of birth, nationality, country of birth, educational level, marital status, work, family responsibilities and data on their previous history of cervical cancer screening as if they ever did a cytology, the result of the last cytology and number of screening tests lifetime (sociodemographic questionnaire). Also, among the women who collects the self-sampling there was available information about questions on acceptability and practicalities of sampling procedures (acceptability questionnaire).
The project was approved by the ethical committees of the Bellvitge University Hospital (number PR223/17), IDIAP Jordi Gol (number P18/099) and Maternal and Child Insular University Hospital Complex (number 2018-178-1). Any information regarding the identification of patients is anonymized before analysis.
The self-sample is collected using the Rovers Medical Devices Evalyn Brush from Rovers.
Detection of HPV of all the samples from Catalonia is carried out at the Infections and Cancer laboratory of the Catalan Institute of Oncology in Barcelona, while those from the Canary Islands is processed in the Pathological Anatomy Service of the Maternal and Child Insular University Hospital Complex of Las Palmas de Gran Canaria.
All the samples are processed using Cobas HPV test Roche Cobas 4800 HPV test. Cobas HPV test is an in-vitro quantitative detection technique for high-risk HPV DNA by polymerase chain reaction (PCR) amplification and can detect a total of 14 HR-HPV subtypes and provides the results of HPV 16 and HPV 18, and the pooled results of the other 12 subtypes in the assay.
Data from both sociodemographic and acceptability questionnaires and test results (clinical and self-sampling) are collected using Research Electronic Data Capture call REDCap tools hosted at Catalan Institute of Oncology. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources. Personal involved in the project had access to the REDCap platform through a username and password and enter data of each woman who has been anonymized.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Active comparator | Device: Explanation on how to use self-sampling device and training in the screening visit.The Health professional shows the woman how to use the self-sampling device (Evalyn Brush) and then she collects a self-sample at the health centre as a training. |
| No prior training group | Placebo comparator | Other: Only explanation on how to use self-sampling device.The Health professional shows the woman how to use the self-sampling device (Evalyn Brush). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged 30 to 65 years (both inclusive) with a adequate prior history of cervical cancer screening (last cytological screening test no more than four years ago).
Key exclusion criteria (6 listed)
- Women under 30 years of age.
- Women over 65 years of age.
- Pregnant women.
- Women with hysterectomy.
- Women between 30 and 65 years of age who underwent the last screening test more than four years ago.
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 |
|---|---|---|
| Explanation on how to use self-sampling device and training in the screening visit.Also: Evalyn BrushDuring the screening visit, woman is offered to participate in the study. If she accepts, informed consent is signed, a sociodemographic questionnaire is collected, and a cervical sample is collected for HPV detection by the health professional in the consultation. Then, the professional informs the woman of how to carry out the self-collection using Evalyn Brush and after the woman collects an HPV sample by self-sampling in the same medical center as a trainning. Finally, a new cervibrush (Evalyn brush) is given to the woman for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, woman is requested to return the self-collected sample together with the questionnaire in person to the recruitment centre. | Device | Training group |
| Only explanation on how to use self-sampling device.During the screening visit, woman is offered to participate in the study. If she accepts, informed consent is signed, a sociodemographic questionnaire is collected, and a cervical sample is taken for HPV detection by the health professional in the consultation. Then, the professional informs the woman of how to carry out the self-collection using Evalyn. Finally, a Evalyn brush is given to the woman for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, woman is requested to return the self-collected sample together with the questionnaire in person to the recruitment centre. | Other | No prior training group |
Primary outcome
Self-sampling acceptability for cervical cancer screening
Time frame: 2 months
Acceptability will be compared by study arm and evaluated as 1) proportion of women that return the self-sampling device, 2) proportion of women that return the self-sampling device and respond to favour future screening with self-sampling. This will be evaluated according to the sociodemographic variables of the participants and the results of the acceptability questionnaire that each woman has filled out.
2 secondary outcomes
The cost-effectiveness of cervical Self-Sampling on public health system in Spain
Time frame: This is a mathematical and cost analisis. No participants are assessed (time frame 2 years)
HPV test agreement between self-sampling and clinician-collected samples
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Background: PubMed 34861338Serrano B, Ibanez R, Robles C, Peremiquel-Trillas P, de Sanjose S, Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening. Prev Med. 2022 Jan;154:106900. doi: 10.1016/j.ypmed.2021.106900. Epub 2021 Nov 30.
- Derived from this study: PubMed 37308042Ibanez R, Roura E, Acera A, Andujar M, Pavon MA, Bruni L, de Sanjose S. HPV self-sampling among cervical cancer screening users in Spain: A randomized clinical trial of on-site training to increase the acceptability. Prev Med. 2023 Aug;173:107571. doi: 10.1016/j.ypmed.2023.107571. Epub 2023 Jun 10.
- Individual participant dataSharing planned: No
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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.
Raquel Ibáñez Pérez, Dra. principal investigator
Institut Català d'Oncologia - IDIBELL
Silvia de Sanjosé Llongueras, Dra. study director
National Cancer Institute (NCI)
Amelia Acera, Dra. study chair
Institut Català de la Salut
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explanation on how to use self-sampling device and training in the screening visit. and Only explanation on how to use self-sampling device. in people with HPV-Related Cervical Carcinoma and Self-sampling, run by Institut d'Investigació Biomèdica de Bellvitge at 3 sites in Spain.
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 1 inclusion and 6 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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. Some participants in this study may receive a placebo. 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 Raquel Ibáñez Pérez, Dra. (932607812, raquelip@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-sampling acceptability for cervical cancer screening (time frame: 2 months). 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 NCT05314907, which also lists 2 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 14 Apr 2022.