Status:
RECRUITING
Rice Technologies for Cervical Cancer Screening and Diagnosis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Eduardo Mondlane University
William Marsh Rice University
Conditions:
Cervical Cancer
Eligibility:
FEMALE
25-49 years
Phase:
NA
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 o...
Detailed Description
This is a prospective, single-arm community trial involving 678 women aged 25 to 49 years for evaluation of positive cervical cancer screening tests (abnormal cytology, VIA+ and/or HPV+ test). Eligibl...
Eligibility Criteria
Inclusion
- 25 - 49 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
- 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
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
678 Patients enrolled
Trial Details
Trial ID
NCT05372484
Start Date
March 24 2021
End Date
March 30 2028
Last Update
August 5 2025
Active Locations (4)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
2
José Macamo General Hospital and Health Center
Maputo, Mozambique, 1106
3
Maputo Central Hospital
Maputo, Mozambique, 1106
4
Mavalane Hospital and Health Center
Maputo, Mozambique, 1108