Rice Technologies for Cervical Cancer Screening and Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal optical imaging.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 25 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Mozambique
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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). Eligible women will be offered enrollment at the time of their consultation for a follow-up of their abnormal cervical cancer screening test.
Participating centers include: 1) Mavalane Hospital and Health Center and 2) José Macamo General Hospital (José Macamo), 3) Maputo Central Hospital. After providing the informed consent, the participant will answer a short questionnaire that will include demographic information and medical background, including HIV status (HIV-negative, positive, or unknown, and, among women with HIV-positive tests, HIV viral load and CD4 cell count, if available), and cervical cancer screening test results.
The patient will undergo a rapid urine - POC pregnancy test (within 14 days from the date of enrollment). Each participant will then receive instructions and will provide two cervico-vaginal samples taken by the patient herself (self-collection).
The patient will then undergo a pelvic examination with two cervical samples taken by the healthcare provider. 7. A sample taken by the patient herself (self-collection) and a sample taken by the provider will be sent for an HPV test using GeneXpert. Similarly, samples taken by the patient herself (self-collection) and collected by the provider will be stored for the Rice POC rapid HPV test.
The patient will then undergo multimodal imaging. Images/videos of the cervix will be obtained using the mobile colposcope/smartphone and HRME images/videos will be also obtained.
Interventions
- Device 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 measures
- Development of multimodal optical imaging system [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Mozambique · 3 centers
- José Macamo General Hospital and Health Center — Maputo
- Maputo Central Hospital — Maputo
- Mavalane Hospital and Health Center — Maputo
United States · 1 center
- M D Anderson Cancer Center — Houston
Publications
- Novak EN, Hansen CJ, Wazir Z, Ma A, Carns J, Atif H, Montealegre JR, Scheurer ME, Lorenzoni C, Rosen DG, Salcedo MP, Schmeler KM, Richards-Kortum RR. Point-of-care hrHPV mRNA detection with reverse transcription recombinase polymerase amplification on a portable fluorimeter from provider-collected cervical samples in Maputo, Mozambique. Infect Agent Cancer. 2026 Jun 23;21(1):52. doi: 10.1186/s1302 PMID 42337609
Identifiers
NCT: NCT05372484 · 2020-0549 · NCI-2022-03776