Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

NCT00602368 | Completed

• 3 other identifiers: CDR0000581286BCCR-H03-61235P01CA082710
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia. PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia.

Conditions

Cervical Cancer; Precancerous Condition

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN

  Measure normal and abnormal sites during colposcopy and compare this to pathology.

  For length of study

Interventions

histological technique OTHER

laboratory biomarker analysis OTHER

colposcopic biopsy PROCEDURE

colposcopy PROCEDURE

light-scattering spectroscopy PROCEDURE

loop electrosurgical excision procedure PROCEDURE

Eligibility Criteria

• Age: 19 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.
• 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 individuals will be excluded.
• Individuals that have had an operation to remove their cervix will be excluded.
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

BC Cancer Research Centre

Vancouver, British Columbia, V5Z 1L3, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Precancerous Conditions; Uterine Cervical Dysplasia

Interventions

Histological Techniques; Colposcopy

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Dianne M. Miller, M.D.

  British Columbia Cancer Agency, Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: January 28, 2008
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

CA (1)