Clinical trial NCT05372484: Rice Technologies for Cervical Cancer Screening and Diagnosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Human Papilloma virus
Point-of-care HPV Test
Multimodal Optical Imaging
Screening
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Eduardo Mondlane University
name: William Marsh Rice University
First posted: 2022-05-12
Enrollment: 678
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of multimodal optical imaging system
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Maputo
country: Mozambique
facility: José Macamo General Hospital and Health Center
city: Maputo
country: Mozambique
facility: Maputo Central Hospital
city: Maputo
country: Mozambique
facility: Mavalane Hospital and Health Center
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathleen Schmeler, MD
role: PRINCIPAL_INVESTIGATOR
References: