New methods 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
This study is testing a new quick test for HPV and a special imaging system to see if they can better detect cervical cancer in women who have already had positive screening results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 678 (estimated) |
| Ages | 25 Years to 49 Years |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 4 sites (Houston, Texas and 3 other locations) |
| Trial ID | NCT05372484 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a lateral flow test for detecting HPV at the point of care, comparing it to existing HPV tests. It also assesses the diagnostic accuracy of a multimodal optical imaging system for identifying cervical dysplasia, using histopathology as the gold standard. The trial involves 678 women aged 25 to 49 who have received positive cervical cancer screening results. Participants will provide self-collected and provider-collected samples for HPV testing and undergo a pelvic examination.
Who should consider this trial
Good fit: Ideal candidates are women aged 25 to 49 with a positive cervical cancer screening test.
Not a fit: Patients who are under 25 or over 49 years old, or those who have undergone a total hysterectomy, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and accessible cervical cancer screening methods.
How similar studies have performed: Other studies have shown promise in using point-of-care HPV testing and optical imaging for cervical cancer screening, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 3 other locations
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- José Macamo General Hospital and Health Center — Maputo, Mozambique (Recruiting)
- Maputo Central Hospital — Maputo, Mozambique (Recruiting)
- Mavalane Hospital and Health Center — Maputo, Mozambique (Recruiting)
Study contacts
- Principal investigator: Kathleen Schmeler, MD — M.D. Anderson Cancer Center
- Study coordinator: Mila Salcedo, MD, PhD
- Email: mpsalcedo@mdanderson.org
- Phone: (832) 696-6794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.