PEER Trial: Part 2

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05372484

Collaborator

Eduardo Mondlane University (Other), William Marsh Rice University (Other)

678

Enrollment

Locations

Arm

21.2

Anticipated Duration (Months)

169.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with the commercially available GeneXpert 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Device: Multimodal optical imaging	N/A

Detailed Description

This is a prospective, single-arm community trial involving 678 women aged 30 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

678 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

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

Actual Study Start Date :

Mar 24, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multi-Modal Optical Imaging 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.	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.

Arm

Intervention/Treatment

Experimental: Multi-Modal Optical Imaging

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.

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.

Outcome Measures

Primary Outcome Measures

Development of multimodal optical imaging system [through study completion, an average of 1 year]
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 Criteria

Criteria

Ages Eligible for Study:

30 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

30 - 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)
Willing and capable of providing an informed consent

Exclusion Criteria:

Women under 30 or over 49 years old
Women who have undergone a total hysterectomy (with removal of the cervix)
Women who are pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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