An interventional study of BD SurePath Plus Pap test and BD SurePath Pap test in Uterine Cervical Neoplasms, Uterine Cervical Cancer and Neoplasms, Squamous Cell, sponsored by Becton, Dickinson and Company. Terminated at 1 site in United States. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Becton, Dickinson and Company · Interventional and Diagnostic
This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to undergo colposcopy and biopsy/ECC. Subjects with abnormal cytology results with biopsy results of less than or equal to CIN1 or CIN2 untreated will be asked to return in 6-8 months for follow-up testing. Subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).
This is a pivotal, multi-center in vitro diagnostic study comparing the BD SurePath Plus Pap test to current practice (cytologic examination utilizing the BD SurePath liquid-based Pap test with conjunctive HPV testing) for the detection of cervical cancer and high-grade cervical disease (collectively referred to as CIN2+) in women.
The new BD SurePath Plus Pap Test combines a traditional Papanicolaou staining for cellular morphology, with brown nuclear immunostaining resulting from the over-expression of specific protein biomarkers, on one slide, to improve the detection of high-grade cervical disease and cervical cancer (collectively referred to as CIN2+).
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's enrollment of 5,859 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Becton, Dickinson and Company is the lead sponsor of 61 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Study subjects must give voluntary written to participate in this study.
High-risk is defined as:
Exclusion Criteria:
Subjects who are 36 years of age or greater who are not high risk, and/or:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.
Device: BD SurePath Plus Pap test · Device: BD SurePath Pap test · Procedure: colposcopy with biopsy/ECC · Device: HPV DNA test
Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.
Device: BD SurePath Plus Pap test · Device: BD SurePath Pap test · Device: HPV DNA test
BD SurePath Plus Pap test
BD SurePath Plus Pap test
Colposcopy with biopsy/ECC for subjects with 1)BD SurePath Pap NILM, but HPV positive, or 2) BD SurePath Plus Pap test result of ASC-US or higher 3)BD SurePath Pap ASC-US or higher
digene HC2 HPV DNA test
Also known as: digene HC2 HPV DNA test
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Estimate the sensitivity, specificity, positive predictive value and negative predictive value of the BD SurePath Plus Pap test in detecting cervical disease as defined as CIN2 or higher
Time frame: 10 months
Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.
Time frame: 10 months
| Milestone | All Study Participants |
|---|---|
| Started | 5859 |
| Completed | 5416 |
| Not completed | 443 |
| Withdrew: Pregnancy | 88 |
| Withdrew: >36/normal history | 50 |
| Withdrew: Age | 3 |
| Withdrew: Hpv vaccine history | 28 |
| Withdrew: Hpv vaccine after enrollment | 17 |
| Withdrew: Hysterectomy | 2 |
| Withdrew: Hysterectomy post enrollment | 1 |
| Withdrew: Inclusion/exclusion violation | 3 |
| Withdrew: Informed consent form violation | 30 |
| Withdrew: Incorrect visit | 3 |
| Withdrew: No florida lab license | 20 |
| Withdrew: Out of window | 42 |
| Withdrew: Sample processing/storage | 92 |
| Withdrew: Site amendment prohibited colposcopy | 11 |
| Withdrew: Site/subject non-compliance | 44 |
| Withdrew: Missing sample | 9 |
Estimate the sensitivity, specificity, positive predictive value and negative predictive value of the BD SurePath Plus Pap test in detecting cervical disease as defined as CIN2 or higher
| Percent | SurePath Plus | SurePath Pap |
|---|---|---|
| Sensitivity (ASC-US+) | 84.9 (77.4 to 90.2) | 71.4 (62.7 to 78.8) |
| Specificity (ASC-US+) | 84.7 (83.5 to 85.9) | 88.7 (87.5 to 89.7) |
| PPV (ASC-US+) | 16.7 (15.1 to 18.2) | 18.5 (16.2 to 20.7) |
| NPV (ASC-US+) | 99.4 (99.0 to 99.6) | 98.9 (98.5 to 99.1) |
| Sensitivity (ASC-H+) | 65.5 (56.6 to 73.5) | 43.7 (35.1 to 52.7) |
| Specificity (ASC-H+) | 92.2 (91.2 to 93.1) | 94.4 (93.5 to 95.1) |
| PPV (ASC-H+) | 23.2 (20.1 to 26.3) | 21.8 (17.8 to 26.1) |
| NPV (ASC-H+) | 98.7 (98.3 to 99.0) | 97.9 (97.6 to 98.2) |
| Sensitivity (LSIL+) | 58.0 (49.0 to 66.5) | 40.3 (32.0 to 49.3) |
| Specificity (LSIL+) | 93.4 (92.5 to 94.2) | 94.7 (93.8 to 95.4) |
| PPV (LSIL+) | 24.0 (20.4 to 27.6) | 21.4 (17.2 to 25.9) |
| NPV (LSIL+) | 98.4 (98.1 to 98.7) | 97.8 (97.5 to 98.1) |
| Sensitivity (HSIL+) | 37.8 (29.6 to 46.8) | 16.0 (10.5 to 23.6) |
| Specificity (HSIL+) | 98.3 (97.8 to 98.7) | 99.8 (99.6 to 99.9) |
| PPV (HSIL+) | 45.0 (36.5 to 53.3) | 76.0 (56.9 to 88.3) |
| NPV (HSIL+) | 97.8 (97.5 to 98.1) | 97.1 (96.9 to 97.3) |
| percent | SurePath Plus With Immunostain | SurePath Pap With HPV |
|---|---|---|
| Sensitivity (ASC-US) | 78.8 (62.2 to 89.3) | 87.9 (72.7 to 92.5) |
| Specificity (ASC-US) | 45.7 (38.8 to 52.9) | 41.5 (34.7 to 48.6) |
Collected over 10 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Evaluable Participants | 0/3,731 (0%) | 0/3,731 (0%) | 0/3,731 (0%) |
Participants with evaluable samples.
| Age, Categorical(Participants) | All Evaluable Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3731 |
| >=65 years | 0 |
| Sex/Gender, Customized(Participants) | All Evaluable Participants |
|---|---|
| Female | 3731 |
| Ethnicity (NIH/OMB)(Participants) | All Evaluable Participants |
|---|---|
| Hispanic or Latino | 889 |
| Not Hispanic or Latino | 2842 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Evaluable Participants |
|---|---|
| United States | 3731 |
The record gives a start of Sep 2010, a primary completion of Mar 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
Results were first posted in May 2021, 9 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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