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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-03776 | Other Identifier | NCI-CTRP-Clinical Trial Reporting Registry |
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| Name | Class |
|---|---|
| Eduardo Mondlane University | OTHER |
| William Marsh Rice University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-Modal Optical Imaging | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal optical imaging | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of multimodal optical imaging system | 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) | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mila Salcedo, MD, PhD | Contact | (832) 696-6794 | mpsalcedo@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Schmeler, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42337609 | Derived | 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. doi: 10.1186/s13027-026-00772-5. Online ahead of print. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| José Macamo General Hospital and Health Center | Recruiting | Maputo | 1106 | Mozambique |
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| Maputo Central Hospital | Recruiting | Maputo | 1106 | Mozambique |
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| Mavalane Hospital and Health Center | Recruiting | Maputo | 1108 | Mozambique |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |