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Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
N/A
Waitlist Available
Research Sponsored by Abbott Molecular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests two methods of collecting cervical cell samples in women undergoing routine screening. It aims to see which method is better at detecting abnormal cells and high-risk HPV, which could indicate a need for further examination.
Eligible Conditions
- Human Papillomavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3
Secondary study objectives
Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Alinity m HR HPVExperimental Treatment1 Intervention
The Alinity m HR HPV IUO assay is a qualitative in vitro test that amplifies and detects HR HPV DNA in cervical cells collected in liquid media. The assay can differentiate between HPV 16, HPV 18, HPV 45 and non-HPV 16/18/45 genotypes \[(31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68)\].
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alinity m HR HPV
2021
N/A
~14940
Find a Location
Who is running the clinical trial?
Abbott MolecularLead Sponsor
2 Previous Clinical Trials
264 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Alinity m HR HPV
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Human Papillomavirus Patient Testimony for trial: Trial Name: NCT04746872 — N/A