APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results

NCT01384370 | Completed

• 1 other identifier: HPVGTS-US10-002
• Study Type: observational
• Target: 1,260
• Locations: 1 country
• Sites: 3

Brief Summary

In both the ASC-US Study and Adjunct Study populations, the objectives are to:

• evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and
• evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45

  Sensitivity (%) = TP/(TP + FN) x 100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status \<CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status \<CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay

  6 months

• Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples

  Specificity (%) = TN/(TN + FP) x100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status \<CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status \<CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay

  6 months

Study Arms (1)

AHPV positive and negative subjects

Eligibility Criteria

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

Study Population

AHPV Assay positive results (\~310 from subjects with a consensus histology result of \<CIN2 or indeterminate disease status and 70 from subjects with CIN2+) * 150 randomly selected AHPV Assay negative samples from subjects with a consensus histology result of \<CIN2 and All AHPV Assay negative samples from subjects with CIN2+ (\~13 samples) * 300 from subjects with a consensus histology result of \<CIN2 or indeterminate disease status, 15 from subjects with CIN2+, and 200 from subjects who did not attend the colposcopy visit) Approximately 150 randomly selected APTIMA HPV Assay negative samples from subjects with a consensus histology result of \<CIN2 All APTIMA HPV Assay negative samples from subjects with CIN2+ (approximately 5 samples)

You may qualify if:

• the subject attended a colposcopy visit, and
• the referral Pap sample had a valid APTIMA HPV Assay result, and
• the sample had an APTIMA HPV Assay positive result, or
• the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 \[CIN2\] or more severe (eg, CIN2, CIN grade 3 \[CIN3\], or cervical cancer; "CIN2+"), or
• the sample had an APTIMA HPV Assay positive result, or
• the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of CIN2+, or

Sponsors & Collaborators

• Gen-Probe, Incorporated: lead

Study Sites (3)

North Shore LIJ Health System Laboratories

Lake Success, New York, 11042, United States

Location

Laboratory Corporation of America

Burlington, North Carolina, 27215, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic, Inc., Marlborough, Massachusetts) with commercially available collection devices (broom-type collection device or cytobrush/spatula combination)\* may be tested with the AHPV-GT Assay either pre- or post-Pap processing.

MeSH Terms

Conditions

Papillomavirus Infections

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

Study Officials

• Tadd S Lazarus, M.D.

  Gen-Probe, Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: June 29, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

US (3)