Clinical trial · Interventional
Intended Use Study of the BD SurePath Plus™ Pap
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decided not to pursue commercialization of the product
Summary
Brief summary (as posted)
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).
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Histologic Type | — | UNRESOLVED | — |
| Neoplasms, Glandular and Epithelial | Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Neoplasms, Squamous Cell | Squamous Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Papilloma | Papilloma | ONTOLOGY_EXACT | 0.98 |
| Uterine Cervical Cancer | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BD SurePath Pap test | Device | — | UNRESOLVED |
| BD SurePath Plus Pap test | Device | — | UNRESOLVED |
| colposcopy with biopsy/ECC | Procedure | — | UNRESOLVED |
| HPV DNA test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Participants with Cervical Disease
- description
- Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.
- interventionNames
- Device: BD SurePath Plus Pap test
- Device: BD SurePath Pap test
- Procedure: colposcopy with biopsy/ECC
- Device: HPV DNA test
- type
- EXPERIMENTAL
- label
- Participants without Cervical Disease
- description
- Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.
- interventionNames
- Device: BD SurePath Plus Pap test
- Device: BD SurePath Pap test
- Device: HPV DNA test
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: Study subjects must give voluntary written informed consent to participate in this study. \- Females ages 18 - 35 years, inclusive; or women at high- risk for cervical cancer or its precursor lesions. High-risk is defined as: * Have had a previous high-risk HPV positive test in the last 5 years; or * Have had an abnormal Pap test (ASC-US or higher) in the last 5 years; or * Have not been screened for cervical cancer by either a Pap test or HPV test in the last 5 years. Exclusion Criteria: * Subjects who are 36 years of age or greater who are not high risk, and/or: 1. Have not had an abnormal Pap in the last 5 years; or 2. Have not had a positive HPV test in the last 5 years; or 3. Have been screened in the last 5 years without an abnormal Pap or HPV result * Subjects known to be pregnant or planning to become pregnant prior to the potential six months follow-up visit (self-reported). Subjects who decide to become pregnant prior to the six-month follow up visit or found to be pregnant after the first visit, but prior to the six-month follow-up visit will be terminated from further study participation at that time * Subjects who have had a prior complete or partial hysterectomy involving removal of the cervix. * Subjects who have had an application of chemical compounds to the cervical area within the 24 hours prior to study entry, e.g., acetic acid, iodine, spermicide, douche, anti-fungal medications, etc. * Subjects on whom conization, LEEP, laser surgery, or cryosurgery has been performed within the past five months. * Subjects currently undergoing radiation and/or chemotherapy. * Subjects under the age of 18. * Subjects who have previously received a HPV vaccine with any number of doses.
References
Publications (0)
Data not yet available