Combined Digital Colposcopy Analysis to Improve Cervical Precancer and Cancer Detection

NCT01094132 | Completed Phase 2

• 3 other identifiers: BCCR-H09-03303P01CA082710H09-03303
• Study Type: interventional
• Target: 551
• Locations: 2 countries
• Sites: 3

Brief Summary

Precancerous lesions of the cervix occur frequently and are treatable. This justifies a population-based screening program. Following an abnormal Pap smear, patients are referred for a colposcopic exam to confirm the presence/stage of disease and select appropriate treatments. Unfortunately, these approaches do not detect all lesions or can sometimes give 'false positive' results (resulting in overtreatment). We are testing a device called a 'multispectral digital colposcope' to determine whether it is more effective at detecting precancerous cervical lesions than existing tools. Success in our study will make diagnoses more accurate and reduce the costs associated with unnecessary treatments.

Conditions

Cervical Cancer; Precancerous Condition

Keywords

cervical cancer; cervical intraepithelial neoplasia grade 1; cervical intraepithelial neoplasia grade 2; cervical intraepithelial neoplasia grade 3; Nonmalignant Condition

Outcome Measures

Primary Outcomes (1)

• Detection of cancer or pre-cancerous abnormalities of the cervix by multispectral digital colposcope.

  All study subjects will be evaluated for cervical abnormalities by 1) standard colposcopy and 2) the trial device (multispectral digital colposcope + wand). Results from each device will be compared, both in terms of the presence/absence of abnormalities and the stage/grade of abnormalities detected by both tools. Histopathological review for cervical abnormalities will be taken as the gold standard against which standard colposcopy and trial device results are measured.

  Standard colposcopy and trial device (MDC + wand) results will be obtained during the clinic visit. Histopathological results for comparison will be available within a few days of the clinic visit.

Study Arms (1)

Review by colposcopy + multispectral digital colposcopy

OTHER

All patients belong under this arm, as all will be reviewed by both conventional colposcopy and by Multispectral Digital Colposcopy (MDC). The nature of these techniques are explained below.

Device: Multispectral Digital Colposcope (MDC)

Interventions

Multispectral Digital Colposcope (MDC) DEVICE

The MDC has 2 components: an optical probe \& a multispectral colposcope. The optical wand makes use of fluorescence \& reflectance spectroscopy; a light is shone on the cervix and the wand reports what it sees to a computer. Since cancer \& healthy cells interact differently with light, a computer can detect abnormalities. The multispectral colposcope is based on a conventional colposcope, which is already widely used. However, it is also able to produce fluorescence \& polarized reflectance images of the entire cervix. Computer analysis of these images can detect abnormalities on the cervix, defining their location and shape. This trial involves combined analysis of MDC data. This may lead to more effective diagnosis of cervical abnormalities. The MDC will be used with standard care for patients presenting with cervical abnormalities (as detected by a Pap test). The MDC will not be used to guide patient management decisions. All study subjects will receive this same intervention.

Review by colposcopy + multispectral digital colposcopy

Eligibility Criteria

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

You may qualify if:

• Included subjects will be ≥18 years old.
• Included subjects will not be pregnant or breast feeding.
• Included subjects will have a negative urine pregnancy test.
• Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
• Included subjects will indicate understanding of the study.
• Included subjects will provide informed consent to participate.

You may not qualify if:

• Individuals \<18 years old will be excluded.
• Pregnant and breast feeding individuals will be excluded.
• Individuals that have had an operation to remove their cervix will be excluded.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• National Cancer Institute (NCI): collaborator
• Texas Tech University Health Sciences Center: collaborator
• Brookdale University Hospital Medical Center: collaborator
• William Marsh Rice University: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (3)

Brookdale Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

Texas Tech Health Sciences Center

El Paso, Texas, 79905, United States

Location

Vancouver General Hospital - Women's Clinic (G&L Diamond Centre)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Precancerous Conditions; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; 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 Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 26, 2010
• Study Start: December 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: November 9, 2016
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

US (2); CA (1)