Cervical CancerNCT05059015
Human Papilloma Virus (HPV) Self-collection and Women Adherence
A study testing CERVICAL HPV and SELF SAMPLING HPV in people with Cervical Cancer and HPV Infection, run by Instituto Nacional de Cancerologia, Columbia at 1 site in Colombia.
Trial summary
Despite declining mortality in high-income countries, cervical cancer continues to be a public health problem in low and middle -income countries. HPV tests have shown a better sensibility and a higher capacity of reducing mortality than cytology based-screening. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, HPV Infection
- What is being tested?
- CERVICAL HPV and SELF SAMPLING HPV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteColombia
- Study dates
- 1 May 2019to 3 Dec 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 30-65 years old
- No history of cytology or any other screening test for cancer of the cervix in the past 5 years
- Be linked to one of the health providing entities participating in the study
- Women who sign the informed consent.
Who cannot join
- Women 30-65 years old
- No history of cytology or any other screening test for cancer of the cervix in the past 5 years
- Be linked to one of the health providing entities participating in the study
- Women who sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Instituto Nacional de Cancerología
Bogotá, Cundinamarca, 00000
About this study
Official title: Effect of HPV Self-collection in Adherence to Cervical Cancer Screening Algorithms
Despite declining mortality in high-income countries, cervical cancer continues to be a public health problem in low and middle -income countries. HPV tests have shown a better sensibility and a higher capacity of reducing mortality than cytology based-screening. Greater participation has been demonstrated with the use of HPV self-testing when it is offered to women with a poor screening history; however, it is not clear whether getting tested necessarily translates into a greater adherence to the entire clinical protocol, including diagnosis and treatment of precancerous lesions. The aim of this study is to evaluate the effect of the self-testing techniques on the participation and adherence of women to cervical cancer screening.
Read the detailed description
The investigators will perform a randomized clinical trial with three arms including: regular HPV with cytology triage, colpo/biopsy, and treatment if indicated; HPV self-collection without cytology triage but with colpo/biopsy and treatment if indicated, HPV self-collection with immediate treatment for women with positive test results. This study will be carried out in two different settings with differential access to diagnosis and treatment. Two methods will be used for inviting women and collecting samples: mail and door-to-door. Participation (screening uptake) and adherence to the clinical protocol (compliance with diagnosis and treatment) will be evaluated.
- Conditions
- Cervical Cancer, HPV Infection
- Being tested
- CERVICAL HPV, SELF SAMPLING HPV
- Keywords
- Cervical Cancer, Screening programs, HPV tests
- 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.
CERVICAL HPVDiagnostic test
A screening test with an HPV test is performed by a health professional plus cytology taking, if it reports positive, colposcopy and biopsy are taken, those with a CIN2 + report are directed to receive treatment.
SELF SAMPLING HPVDiagnostic test
A screening test is performed with an HPV test by self-testing, if it reports positive, women will receive ablative treatment according to eligibility criteria. If they do not meet the criteria for ablation, they will be referred for excisional treatment.
| Study group | Role | What they receive |
|---|---|---|
| CERVICAL HPV | Active comparator | Routine screening procedure based on HPV tests with cervical sampling by a health personnel Receives: Diagnostic Test: CERVICAL HPV |
| SELF SAMPLING HPV ARM 2 | Experimental | Screening based on HPV self-testing and colposcopic evaluation Receives: Diagnostic Test: SELF SAMPLING HPV |
| SELF SAMPLING HPV ARM 3 | Experimental | Arm 3: screening based only on HPV self-testing Receives: Diagnostic Test: SELF SAMPLING HPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation
Number of women that undergo the screening test / total number of women invited.
Measured: 1 year
Adherence
Number of women that undergo the screening test + women who completed the diagnosis and treatment process / total number of women invited + total number of women with a positive screening in follow-up protocols.
Measured: 1 year
Secondary outcomes (3)
Quality of HPV samples
Number of samples suitable for analysis / Total number of samples
Measured: 1 year
CIN2 + rate in the study population
Number of CIN2 + diagnosed / total women screened
Measured: 1 year
CIN2 + rate in population with positive screening
Number of CIN2 + diagnosed / total of women positive at screening
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 May 2019
- Primary completion24 Sep 2020
- Study completion3 Dec 2022 (estimated)
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.
- 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
- Model description
- A randomized clinical trial with three arms will be performed: One group with the routine screening procedure based on HPV tests with cervical sampling by a health personnel ( 3 visits: sampling, colpo/biopsy, treatment of CIN2 +), a second group with a screening based on HPV self-testing and colposcopic evaluation (2 visits: colpo/biopsy, treatment of CIN2 + ); and a third group with a screening based only on HPV self-testing (1 visit: HPV + treatment according to eligibility).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia, Columbia
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059015
- Sponsor's protocol ID
- C19010300532
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HPV Self-collection in Adherence to Cervical Cancer Screening Algorithms
- ClinicalTrials.gov ID
- NCT05059015
- Acronym / sponsor ID
- C19010300532
- Conditions
- Cervical Cancer, HPV Infection
- Keywords
- Cervical Cancer, Screening programs, HPV tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia, ColumbiaOther government
- Study start
- 1 May 2019 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 3 Dec 2022 (estimated)
- First posted
- 28 Sep 2021 (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.
Despite declining mortality in high-income countries, cervical cancer continues to be a public health problem in low and middle -income countries. HPV tests have shown a better sensibility and a higher capacity of reducing mortality than cytology based-screening. Greater participation has been demonstrated with the use of HPV self-testing when it is offered to women with a poor screening history; however, it is not clear whether getting tested necessarily translates into a greater adherence to the entire clinical protocol, including diagnosis and treatment of precancerous lesions. The aim of this study is to evaluate the effect of the self-testing techniques on the participation and adherence of women to cervical cancer screening.
Detailed description
The investigators will perform a randomized clinical trial with three arms including: regular HPV with cytology triage, colpo/biopsy, and treatment if indicated; HPV self-collection without cytology triage but with colpo/biopsy and treatment if indicated, HPV self-collection with immediate treatment for women with positive test results. This study will be carried out in two different settings with differential access to diagnosis and treatment. Two methods will be used for inviting women and collecting samples: mail and door-to-door. Participation (screening uptake) and adherence to the clinical protocol (compliance with diagnosis and treatment) will be evaluated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized clinical trial with three arms will be performed: One group with the routine screening procedure based on HPV tests with cervical sampling by a health personnel ( 3 visits: sampling, colpo/biopsy, treatment of CIN2 +), a second group with a screening based on HPV self-testing and colposcopic evaluation (2 visits: colpo/biopsy, treatment of CIN2 + ); and a third group with a screening based only on HPV self-testing (1 visit: HPV + treatment according to eligibility).
| Arm | Type | Receives |
|---|---|---|
| CERVICAL HPV | Active comparator | Diagnostic Test: CERVICAL HPVRoutine screening procedure based on HPV tests with cervical sampling by a health personnel |
| SELF SAMPLING HPV ARM 2 | Experimental | Diagnostic Test: SELF SAMPLING HPVScreening based on HPV self-testing and colposcopic evaluation |
| SELF SAMPLING HPV ARM 3 | Experimental | Diagnostic Test: SELF SAMPLING HPVArm 3: screening based only on HPV self-testing |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women 30-65 years old
- No history of cytology or any other screening test for cancer of the cervix in the past 5 years
- Be linked to one of the health providing entities participating in the study
- Women who sign the informed consent.
Key exclusion criteria (4 listed)
- Women 30-65 years old
- No history of cytology or any other screening test for cancer of the cervix in the past 5 years
- Be linked to one of the health providing entities participating in the study
- Women who sign the informed consent.
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 |
|---|---|---|
| CERVICAL HPVA screening test with an HPV test is performed by a health professional plus cytology taking, if it reports positive, colposcopy and biopsy are taken, those with a CIN2 + report are directed to receive treatment. | Diagnostic test | CERVICAL HPV |
| SELF SAMPLING HPVA screening test is performed with an HPV test by self-testing, if it reports positive, women will receive ablative treatment according to eligibility criteria. If they do not meet the criteria for ablation, they will be referred for excisional treatment. | Diagnostic test | SELF SAMPLING HPV ARM 2, SELF SAMPLING HPV ARM 3 |
Primary outcome
Participation
Time frame: 1 year
Number of women that undergo the screening test / total number of women invited.
Adherence
Time frame: 1 year
Number of women that undergo the screening test + women who completed the diagnosis and treatment process / total number of women invited + total number of women with a positive screening in follow-up protocols.
3 secondary outcomes
Quality of HPV samples
Time frame: 1 year
CIN2 + rate in the study population
Time frame: 1 year
CIN2 + rate in population with positive screening
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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 study testing CERVICAL HPV and SELF SAMPLING HPV in people with Cervical Cancer and HPV Infection, run by Instituto Nacional de Cancerologia, Columbia at 1 site in Colombia.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Dec 2021. 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 Colombia. 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.
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?
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?
Participation (time frame: 1 year). The study lists 2 primary outcomes in all. 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 10 Dec 2021.