Cervical Intraepithelial NeoplasiaNCT05078528
Low-cost Imaging Technology for Global Prevention of Cervical Cancer
A study testing Multimodal Mobile Colposcope (MMC) in people with Cervical Intraepithelial Neoplasia, run by Barretos Cancer Hospital at 2 sites in Brazil.
Trial summary
Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated… Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Multimodal Mobile Colposcope (MMC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Sep 2021to 3 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women >25 years of age;
- Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;
- Women of childbearing potential must have a negative urine or blood pregnancy test;
- Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.
Who cannot join
- Women under 25 years of age;
- Women who have undergone hysterectomy with removal of the cervix;
- Women with known allergy to proflavine or acriflavine;
- Women who are pregnant or nursing at the time of enrollment;
- Incapacitated women or in vulnerable situations or who are not willing to give consent;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Barretos Cancer Hospital
Barretos, São Paulo, 14784-400
Júlio César P Resende, MD,PhD
- Recruiting
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Mila P Salcedo, MD, PhD
About this study
Official title: Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Multimodal Mobile Colposcope (MMC)
- Keywords
- image analysis, cancer prevention, cervical intraepithelial neoplasia
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Mobile Colposcope (MMC)Device
Women referred for colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group - MMC | Experimental | Imaging of study participants will be performed during the colposcopy examination. The mobile colposcope and the confocal imaging probe, together referred to as the Multimodal Mobile Colposcope (MMC), will be used to image and/or record videos the cervix. Cervical biopsies will be performed using biopsy forceps per standard protocols. Receives: Device: Multimodal Mobile Colposcope (MMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop and validate a Multimodal Mobile Colposcope (MMC)
Image data will be used as a training set to develop and refine image analysis algorithms. Multimodal Mobile Colposcope will be compared with colposcopic impression considering clinical performance (sensitivity, specificity, positive and negative predictive values, and area under the Receiver Operating Characteristic (ROC) curve)
Measured: Day 1 - at the colposcopy day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start20 Sep 2021
- Primary completion3 Aug 2025 (estimated)
- Study completion3 Dec 2025 (estimated)
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 Intraepithelial NeoplasiaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- William Marsh Rice University, M.D. Anderson Cancer Center, Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078528
- Sponsor's protocol ID
- 38969820.9.1001.5437
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunt B, Fregnani JHTG, Brenes D, Schwarz RA, Salcedo MP, Possati-Resende JC, Antoniazzi M, de Oliveira Fonseca B, Santana IVV, de Macedo Matsushita G, Castle PE, Schmeler KM, Richards-Kortum R. Cervical lesion assessment using real-time microendoscopy image analysis in Brazil: The CLARA study. Int J Cancer. 2021 Jul 15;149(2):431-441. doi: 10.1002/ijc.33543. Epub 2021 Apr 3.
PubMed 33811763
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
- ClinicalTrials.gov ID
- NCT05078528
- Acronym / sponsor ID
- 38969820.9.1001.5437
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- image analysis, cancer prevention, cervical intraepithelial neoplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,060 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Collaborators
- William Marsh Rice University, M.D. Anderson Cancer Center, Irmandade Santa Casa de Misericórdia de Porto Alegre
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 3 Aug 2025 (estimated)
- Study completion
- 3 Dec 2025 (estimated)
- First posted
- 14 Oct 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.
Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group - MMC | Experimental | Device: Multimodal Mobile Colposcope (MMC)Imaging of study participants will be performed during the colposcopy examination. The mobile colposcope and the confocal imaging probe, together referred to as the Multimodal Mobile Colposcope (MMC), will be used to image and/or record videos the cervix. Cervical biopsies will be performed using biopsy forceps per standard protocols. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women >25 years of age;
- Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;
- Women of childbearing potential must have a negative urine or blood pregnancy test;
- Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.
Key exclusion criteria (5 listed)
- Women under 25 years of age;
- Women who have undergone hysterectomy with removal of the cervix;
- Women with known allergy to proflavine or acriflavine;
- Women who are pregnant or nursing at the time of enrollment;
- Incapacitated women or in vulnerable situations or who are not willing to give 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 |
|---|---|---|
| Multimodal Mobile Colposcope (MMC)Women referred for colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination. | Device | Experimental group - MMC |
Primary outcome
Develop and validate a Multimodal Mobile Colposcope (MMC)
Time frame: Day 1 - at the colposcopy day
Image data will be used as a training set to develop and refine image analysis algorithms. Multimodal Mobile Colposcope will be compared with colposcopic impression considering clinical performance (sensitivity, specificity, positive and negative predictive values, and area under the Receiver Operating Characteristic (ROC) curve)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Results publication: PubMed 33811763Hunt B, Fregnani JHTG, Brenes D, Schwarz RA, Salcedo MP, Possati-Resende JC, Antoniazzi M, de Oliveira Fonseca B, Santana IVV, de Macedo Matsushita G, Castle PE, Schmeler KM, Richards-Kortum R. Cervical lesion assessment using real-time microendoscopy image analysis in Brazil: The CLARA study. Int J Cancer. 2021 Jul 15;149(2):431-441. doi: 10.1002/ijc.33543. Epub 2021 Apr 3.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Mobile Colposcope (MMC) in people with Cervical Intraepithelial Neoplasia, run by Barretos Cancer Hospital at 2 sites in Brazil.
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 5 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Júlio César P Resende, MD, PhD (+55 (17) 3321-6600 ext. 7086, julio.possati@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop and validate a Multimodal Mobile Colposcope (MMC) (time frame: Day 1 - at the colposcopy day). 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 NCT05078528, 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 6 Feb 2025.