Recruiting

Cervical Cancer

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05372484

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 25 - 49

Healthy Volunteers: Not accepted

Interventions

Multimodal optical imaging

Study Details

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.

Conditions

Cervical Cancer

Study ID

NCT05372484

Start date

Mar 24, 2021

Status verified date

Aug, 2026

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 49

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 25 - 49 year old women
2. Women with a positive cervical cancer screening test (abnormal cytology, positive VIA and/or positive HPV test)
3. Women with intact cervix
4. Women who are not pregnant and with a negative pregnancy test (within 14 days from the date of enrollment) ) and not currently breastfeeding
5. Willing and capable of providing informed consent

Exclusion Criteria:

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

Study Design

Enrollment

678 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Multi-Modal Optical Imaging

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.

Interventions

Multimodal optical imaging

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.

Primary outcome measure

  • Development of multimodal optical imaging system [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Mila Salcedo, MD, PhD

(832) 696-6794mpsalcedo@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Kathleen Schmeler, MD

713-854-9150kschmele@mdanderson.org

Principal Investigator:

Kathleen Schmeler, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Human Papilloma virus
  • Point-of-care HPV Test
  • Multimodal Optical Imaging
  • Screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.