NCT05078528

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,060

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

3.9 years

First QC Date

October 4, 2021

Last Update Submit

February 4, 2025

Conditions

Cervical Intraepithelial Neoplasia

Keywords

image analysiscancer preventioncervical intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

  • 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)

    Day 1 - at the colposcopy day

Study Arms (1)

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.

Device: Multimodal Mobile Colposcope (MMC)

Interventions

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.

Experimental group - MMC

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Barretos Cancer Hospital

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33811763BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Júlio César P Resende, MD, PhD

CONTACT

+55 (17) 3321-6600julio.possati@uol.com.br

Mila P Salcedo, MD, PhD

CONTACT

+1-832-316-3774mpsalcedo@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 14, 2021

Study Start

September 20, 2021

Primary Completion

August 3, 2025

Study Completion

December 3, 2025

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)