Cervical Dysplasia — The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia
Citation(s)
ASCUS-LSIL Traige Study (ALTS) Group Results of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance. Am J Obstet Gynecol. 2003 Jun;188(6):1383-92. doi: 10.1067/mob.2003.457.
Baasland I, Hagen B, Vogt C, Valla M, Romundstad PR Colposcopy and additive diagnostic value of biopsies from colposcopy-negative areas to detect cervical dysplasia. Acta Obstet Gynecol Scand. 2016 Nov;95(11):1258-1263. doi: 10.1111/aogs.13009.
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
Huh WK, Papagiannakis E, Gold MA Observed Colposcopy Practice in US Community-Based Clinics: The Retrospective Control Arm of the IMPROVE-COLPO Study. J Low Genit Tract Dis. 2019 Apr;23(2):110-115. doi: 10.1097/LGT.0000000000000454.
Jeronimo J, Schiffman M Colposcopy at a crossroads. Am J Obstet Gynecol. 2006 Aug;195(2):349-53. doi: 10.1016/j.ajog.2006.01.091. Epub 2006 May 3.
Massad LS, Collins YC Strength of correlations between colposcopic impression and biopsy histology. Gynecol Oncol. 2003 Jun;89(3):424-8. doi: 10.1016/s0090-8258(03)00082-9.
Nam K, Chung S, Kwak J, Cha S, Kim J, Jeon S, Bae D Random biopsy after colposcopy-directed biopsy improves the diagnosis of cervical intraepithelial neoplasia grade 2 or worse. J Low Genit Tract Dis. 2010 Oct;14(4):346-51. doi: 10.1097/LGT.0b013e3181e9635b.
Sawaya GF, Kuppermann M Identifying a "range of reasonable options" for cervical cancer screening. Obstet Gynecol. 2015 Feb;125(2):308-310. doi: 10.1097/AOG.0000000000000670. No abstract available.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.