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Trial record 16 of 21 for:    Open Studies | "Uterine Cervical Dysplasia"

Combined Digital Colposcopy Analysis to Improve Cervical Precancer and Cancer Detection (MDC_Algo)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by British Columbia Cancer Agency
Sponsor:
Collaborator:
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01094132
First received: March 25, 2010
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Precancerous Condition
Device: Multispectral Digital Colposcope (MDC)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Development and Application of a Multispectral Digital Colposcopy Algorithm for Detection of Cervical Intraepithelial Neoplasia and Neoplasia.

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Detection of cancer or pre-cancerous abnormalities of the cervix by multispectral digital colposcope. [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 618
Study Start Date: January 2015
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Review by colposcopy + multispectral digital colposcopy
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)

The MDC has 2 components: an optical wand & 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Included subjects will be ≥18 years old.
  • Included subjects will not be pregnant.
  • 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.

Exclusion criteria:

  • Individuals <18 years old will be excluded.
  • Pregnant individuals will be excluded.
  • Individuals that have had an operation to remove their cervix will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094132

Locations
Canada, British Columbia
Vancouver General Hospital - Women's Clinic (G&L Diamond Centre) Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Sylvia Lam    604-675-8093    sflam@bccrc.ca   
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Michele Follen, MD, PhD Brookdale Hospital and Medical Center
  More Information

No publications provided

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01094132     History of Changes
Other Study ID Numbers: BCCR-H09-03303, P01CA082710, H09-03303
Study First Received: March 25, 2010
Last Updated: October 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by British Columbia Cancer Agency:
cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
Nonmalignant Condition

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014