Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia

NCT02406352 | Unknown

• 1 other identifier: 14-35
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 1

Brief Summary

Although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. Internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. With the device the investigators are developing, known as the Multispectral Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions easier for the patient and for her provider. For the patient, our goal is to reduce the number of clinical visits needed to obtain a diagnosis and treatment and consequently to reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For the provider and the health care system, our goal is to obtain a more accurate diagnosis than the currently available diagnostic methods.

Conditions

Carcinoma in Situ of Uterine Cervix; Cervical Intraepithelial Neoplasias; High Grade Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• Detection of precancerous cervical lesions or cervical cancer

  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 MDC with probe will also be used to collect images of the cervix and spectroscopic measurements with the probe. All measurements will be compared with the biopsies obtained. The MDC with probe will not be used to determine from where the biopsies need to be obtained. One or two additional biopsies will be obtained from tissue that appears to be unaffected. These will be the control biopsies. Patients may refuse to provide the additional biopsies which are not part of the standard of care. Patients scheduled for a treatment with the Loop Electrosurgical Excision Procedure (LEEP) will be asked for consent to obtain one or two biopsies prior to the LEEP procedure, but after anesthesia has been applied.

  At point of care for colposcopy or treatment with LEEP (5 minutes).

Study Arms (1)

Routine colposcopy and MDC with probe

EXPERIMENTAL

The intervention which consists of obtaining cervical images with the MDC and spectroscopic data with the probe will be applied to all participants who agreed to participate in the study during their visit for a colposcopy exam or treatment with a LEEP procedure. A control biopsy will also be obtained from patients who agree to provide it. The control biopsy is a biopsy of cervical tissue that does not appear to have atypical changes when observed through a standard of care colposcope.

Device: Multispectral Digital Colposcope with probe

Interventions

Multispectral Digital Colposcope with probe DEVICE

Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study. The standard of care for research participants will not change.

Routine colposcopy and MDC with probe

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are at least 18 years old
• Are not pregnant (negative urine test) or breastfeeding
• Referred for colposcopy or LEEP treatment
• Can provide written informed consent

You may not qualify if:

• Women who have had a hysterectomy

Sponsors & Collaborators

• Brookdale University Hospital Medical Center: lead

Study Sites (1)

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Michele Follen, MD, PhD

  Brookdale University Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonid Fradkin, PhD

CONTACT

718-240-8225; lfradkin@bhmcny.org

Thelma Carrillo, MPH

CONTACT

718-240-5978; tcarrill@bhmcny.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 2, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)