ACTIVE NOT RECRUITINGNA

Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test

The purpose of this study is to validate a new low-cost, self-collected HPV screening test (ScreenFire) and compare it to the standard provider collected careHPV, for the detection of high grade cervical cancer.

Sponsor

The Cleveland Clinic

Enrollment

9,100 participants

Sites

1 locations

Start Date

February 2023

Completion

December 2027

Human Papilloma VirusScreenFire HPV testcareHPV testColposcopy and biopsy

Enrollment & Timeline

Active, Not Recruiting

Target enrollment (estimated)

Target N

9,100

participants

Sites

locations

Duration

4.8 years

total trial span

Rate

157

pts/month needed

Feb 2023Month 42 of 58Dec 2027

72% of trial timeline elapsed16 months to primary endpoint

At 1 sites, each site needs to enroll approximately 157.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

Sensitivity

4-years

Proportion of true HPV positive cases based on biopsy detected by ScreenFire test via self-collection compared to careHPV via provider collection

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

ACTIVE NOT RECRUITINGNA

Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test

Sponsor

The Cleveland Clinic

Enrollment

9,100 participants

Sites

1 locations

Start Date

February 2023

Completion

December 2027

Human Papilloma VirusScreenFire HPV testcareHPV testColposcopy and biopsy

Enrollment & Timeline

Active, Not Recruiting

Target enrollment (estimated)

Target N

9,100

participants

Sites

locations

Duration

4.8 years

total trial span

Rate

157

pts/month needed

Feb 2023Month 42 of 58Dec 2027

72% of trial timeline elapsed16 months to primary endpoint

At 1 sites, each site needs to enroll approximately 157.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Sensitivity

4-years

Proportion of true HPV positive cases based on biopsy detected by ScreenFire test via self-collection compared to careHPV via provider collection

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

30 Years

Max Age

59 Years

Sex

female

Healthy Volunteers

Yes

View full criteria

Inclusion Criteria:

* Female, aged 30-59

Exclusion Criteria:

* Pregnancy at time of colposcopy/biopsy
* Hysterectomy with surgically absent cervix
* Cervical cancer screening in the past two years
* Prior diagnosis or treatment of invasive cervical cancer

Ask AI

Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)