NCT05372484

Brief Summary

The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with commercially available HPV test and to determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, with the gold reference standard of histopathology.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
678

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 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 Progress73%
Mar 2021Mar 2028

Study Start

First participant enrolled

March 24, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

7 years

First QC Date

April 25, 2022

Last Update Submit

February 11, 2026

Conditions

Cervical Cancer

Keywords

Human Papilloma virusPoint-of-care HPV TestMultimodal Optical ImagingScreening

Outcome Measures

Primary Outcomes (1)

  • Development of multimodal optical imaging system

    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)

    through study completion, an average of 1 year

Study Arms (1)

Multi-Modal Optical Imaging

EXPERIMENTAL

Multi-modal imaging (mobile colposcopy and high resolution imaging) of study participants will be performed during the colposcopy examination. Cervical biopsies will be performed using biopsy forceps per standard protocols.

Device: Multimodal optical imaging

Interventions

Multimodal optical imagingDEVICE

Women referred for colposcopy due to abnormal cervical screening will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.

Multi-Modal Optical Imaging

Eligibility Criteria

Age25 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • year old women
  • Women with a positive cervical cancer screening test (abnormal cytology, positive VIA and/or positive HPV test)
  • Women with intact cervix
  • Women who are not pregnant and with a negative pregnancy test (within 14 days from the date of enrollment) ) and not currently breastfeeding
  • Willing and capable of providing informed consent

You may not qualify if:

  • Women under 25 or over 49 years old
  • Women who have undergone a total hysterectomy (with removal of the cervix)
  • Women who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

José Macamo General Hospital and Health Center

Maputo, 1106, Mozambique

RECRUITING

Maputo Central Hospital

Maputo, 1106, Mozambique

RECRUITING

Mavalane Hospital and Health Center

Maputo, 1108, Mozambique

RECRUITING

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kathleen Schmeler, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mila Salcedo, MD, PhD

CONTACT

(832) 696-6794mpsalcedo@mdanderson.org

Study Design

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

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 12, 2022

Study Start

March 24, 2021

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

March 30, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

MO(3)US(1)