Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer

NCT02574442 | Terminated

• 3 other identifiers: BCCR - H15-01726P01CA082710H15-01726
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this proposal is to determine whether a hand-held confocal microscopy probe may perform better than standard methods in detecting cancer or pre-cancerous abnormalities of the cervix. The confocal probe will provide invivo histopathology-like images of cell morphology and three-dimensional tissue architecture non-invasively in real time.

Conditions

Precancerous Condition; Cervical Cancer

Keywords

cervical intraepithelial neoplasia grade 1; cervical intraepithelial neoplasia grade 2; cervical intraepithelial neoplasia grade 3; adenocarcinoma in situ

Outcome Measures

Primary Outcomes (1)

• Detection of pre-cancer abnormalities of the cervix by the confocal microscopy probe

  Probe measurements on participant's cervix should take no more than 10 minutes during the clinical visit

Study Arms (1)

Initial Colposcopy Visit

Women with a scheduled colposcopy and biopsy appointment at the Women's Clinic at Vancouver General Hospital

Device: In Vivo Confocal Microscopy Probe

Interventions

In Vivo Confocal Microscopy Probe DEVICE

Participants will have 2 areas on their cervical imaged by the confocal probe.

Initial Colposcopy Visit

Eligibility Criteria

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

Study Population

Be scheduled for colposcopy \& biopsy at the Vancouver General Hospital Women's Clinic

You may qualify if:

• indicate understanding of the study
• provide informed consent to participate
• years old or older
• not pregnant and have negative urine pregnancy test
• be schedule for colposcopy \& biopsy at the Vancouver General Hospital Women's Clinic

You may not qualify if:

• they are breast-feeding
• they had an operation to remove their cervix

Sponsors & Collaborators

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

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical biopsies

MeSH Terms

Conditions

Precancerous Conditions; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Adenocarcinoma in Situ

Condition Hierarchy (Ancestors)

Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Marette Lee, MD

  BC Cancer Agency, Gynecologic Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: October 12, 2015
• Study Start: September 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2020
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CA (1)