Clinical trial · Interventional
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
NCT05372484CI-TRIAL-00121250recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal optical imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-Modal Optical Imaging
- description
- 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.
- interventionNames
- Device: Multimodal optical imaging
Primary outcomes (1)
- measure
- Development of multimodal optical imaging system
- timeFrame
- through study completion, an average of 1 year
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNovak 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/s13027-026-00772-5. PMID 42337609