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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05372484
Other study ID # 2020-0549
Secondary ID NCI-2022-03776
Status Recruiting
Phase N/A
First received
Last updated
Start date March 24, 2021
Est. completion date March 30, 2028

Study information

Verified date January 2024
Source M.D. Anderson Cancer Center
Contact Mila Salcedo, PhD
Phone (832) 696-6794
Email mpsalcedo@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 678
Est. completion date March 30, 2028
Est. primary completion date March 30, 2028
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 49 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Mozambique José Macamo General Hospital and Health Center Maputo
Mozambique Maputo Central Hospital Maputo
Mozambique Mavalane Hospital and Health Center Maputo
United States M D Anderson Cancer Center Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center Eduardo Mondlane University, William Marsh Rice University

Countries where clinical trial is conducted

United States,  Mozambique, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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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