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NCT04746872
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
trial testing Alinity m HR HPV in Human Papillomavirus in 14,935 participants. Completed in 3 November 2022.
16 June 2022
Quick facts
| Lead sponsor | Abbott Molecular |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 14,935 |
| Start date | 16 February 2021 |
| Primary completion | 16 June 2022 |
| Estimated completion | 3 November 2022 |
| Sites | 63 locations across United States |
Drugs / interventions tested
- Alinity m HR HPV
Conditions studied
- Human Papillomavirus — all drugs for Human Papillomavirus →
Sponsor
Abbott Molecular
Who can join
25 and older, female only, with Human Papillomavirus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective multicenter interventional study will be conducted to enroll women undergoing routine cervical cancer screening to collect cervical liquid-based cytology (LBC) specimen(s). For all subjects, two cervical specimens will be collected, and one placed into Hologic ThinPrep Pap Test collection kit with PreservCyt Solution (also referred to as ThinPrep specimen) and the other into BD SurePath liquid-based Pap test (also referred to as SurePath specimen). Cytology and HR HPV results will be generated and utilized to determine need for subject referral to colposcopy. Collection of an endocervical curettage (ECC) specimen, and biopsy(ies) if applicable, from women who are referred to colposcopy as a follow up will be conducted according to a standardized protocol. Disease status for each subject will be determined based on cytology, HPV test results, and/or consensus histology review of cervical biopsy specimens.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04746872
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Human Papillomavirus
Currently open trials in the same condition.
- NCT06519994 — Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya · Phase 2 · active not recruiting
- NCT06434337 — Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV) · recruiting
- NCT05365048 — Provider Recommendation and HPV Vaccination · NA · recruiting
- NCT05026138 — Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune) · recruiting
- NCT04708470 — A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04746872 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abbott Molecular
- Last refreshed: 12 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04746872.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing