RecruitingNot ApplicableNCT05372484

Rice Technologies for Cervical Cancer Screening and Diagnosis

Assessment of New Technologies for the Screening and Diagnosis of Cervical Cancer in Mozambique, A Study to be Conducted in Maputo Central Hospital, Mavalane and Jose Macamo General Hospitals and Mavalane Health Center


Sponsor

M.D. Anderson Cancer Center

Enrollment

678 participants

Start Date

Mar 24, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 49 Years

Inclusion Criteria5

  • 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

Exclusion Criteria3

  • 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

Interventions

DEVICEMultimodal 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.


Locations(4)

M D Anderson Cancer Center

Houston, Texas, United States

José Macamo General Hospital and Health Center

Maputo, Mozambique

Maputo Central Hospital

Maputo, Mozambique

Mavalane Hospital and Health Center

Maputo, Mozambique

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NCT05372484


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