Combined Digital Colposcopy Analysis to Improve Cervical Precancer and Cancer Detection (MDC_Algo)
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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. |
- 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: | December 2012 |
| 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 |
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| Canada, British Columbia | |
| Vancouver General Hospital - Women's Clinic (G&L Diamond Centre) | Not yet recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Timon Buys, PhD 604-675-8085 tbuys@bccrc.ca | |
| Principal Investigator: | Michele Follen, MD, PhD | Drexel University |
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 30, 2012 |
| 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:
|
Neoplasms Uterine Cervical Neoplasms Precancerous Conditions Cervical Intraepithelial Neoplasia Carcinoma in Situ Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 17, 2013