Cervical Cancer, Cervical Intraepithelial Neoplasias, Digital Colposcopy, Precancerous Cervical Lesions
Conditions
Brief summary
A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.
Interventions
DEVICEDiagnostic imaging aid for one-visit management of cervical lesions
Sponsors
Brookdale University Hospital Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who are at least 18 years old * Women who are not pregnant as confirmed by a urine test * Women who are not breastfeeding * Women who understand the study procedures and can provide written informed consent
Exclusion criteria
* Women who do not meet the inclusion criteria * Women who have had a hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of precancerous cervical lesions or cervical cancer | At point of care for colposcopy or treatment with LEEP (5 minutes). | Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the handheld imaging research device will also be used to capture cervical images. The images will be analyzed and compared to the biopsies obtained. The imaging device will not be used to make a diagnosis. As part of the research study, one or two additional biopsies will be obtained if the patient agrees. These additional biopsies will serve as the control tissue, since they will be taken from tissue that appears normal through the colposcope. |
Countries
United States
Contacts
Primary ContactLeonid Fradkin, PhD
Backup ContactThelma Carrillo, MPH
Outcome results
None listed