Clinical Correlation Between Self-collected and Physician-collected HPV Screening Kits

NCT05679141 | Completed

• 1 other identifier: HPV102022
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to validate the of the Evalyn®Brush via self-collection to the standard clinician-collected technique using the BD SurePath™ collection vial and Rovers CombiBrush for detection of Human Papillomavirus (HPV). This study will validate the sensitivity and specificity of the Evalyn Brush with the future goal of making this testing approach available for self-collection in the future.

Conditions

HPV Infection; Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Clinical Correlation - Positives

  Samples collected via self-collection correlate \>95% to those clinician-collected

  Through study completion, an average of 12 weeks

• Clinical Correlation - Negatives

  Samples collected via self-collection correlate \>95% to those clinician-collected

  Through study completion, an average of 12 weeks

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population are individuals with a cervix who wish to participate in routine screening for HPV and associated risk for cervical cancers.

You may qualify if:

• Participant visiting the study site for a potential OB/GYN purpose
• Participant \>= 21 years of age
• Participant has a cervix

You may not qualify if:

• Currently menstruating
• Currently pregnant or within 3 months following pregnancy
• Utilized vaginal products within past 48 hrs.
• Experiencing any of following symptoms:
• Pain in lower abdomen Fever Unusual or heavy vaginal discharge Pain / bleeding when having intercourse Painful or frequent urination

Sponsors & Collaborators

• Switch Health Solutions Inc.: lead

Study Sites (1)

Ottawa Medical Group

Ottawa, Ontario, K1E0A8, Canada

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Karam Ramotar, PHD

  Bio-Test Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 10, 2023
• Study Start: February 1, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CA (1)