A comparison of screening methods in two early phase oral leukoplakia clinical trials

Oral Diseases (2012) 18, 720–723 Objectives/Introduction:  Clinical trial accrual for oral dysplasia is difficult in the United States and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screeni...

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Veröffentlicht in:Oral diseases 2012-10, Vol.18 (7), p.720-723
Hauptverfasser: Rosas, RR, Cole, KA, Darrah, L, Rohrer, MD, Rhodus, NL, Ondrey, FG
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container_end_page 723
container_issue 7
container_start_page 720
container_title Oral diseases
container_volume 18
creator Rosas, RR
Cole, KA
Darrah, L
Rohrer, MD
Rhodus, NL
Ondrey, FG
description Oral Diseases (2012) 18, 720–723 Objectives/Introduction:  Clinical trial accrual for oral dysplasia is difficult in the United States and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials. Methods:  For the first trial, we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare professionals. Results:  Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications, and a preneoplastic lesions clinic. Conclusion:  We conclude that significant difficulties resulted from medical record/database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. We feel that persistent direct contact and education of healthcare professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial.
doi_str_mv 10.1111/j.1601-0825.2012.01934.x
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Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials. Methods:  For the first trial, we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare professionals. Results:  Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications, and a preneoplastic lesions clinic. Conclusion:  We conclude that significant difficulties resulted from medical record/database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. 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Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials. Methods:  For the first trial, we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare professionals. Results:  Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications, and a preneoplastic lesions clinic. Conclusion:  We conclude that significant difficulties resulted from medical record/database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. 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Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials. Methods:  For the first trial, we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare professionals. Results:  Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications, and a preneoplastic lesions clinic. Conclusion:  We conclude that significant difficulties resulted from medical record/database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. We feel that persistent direct contact and education of healthcare professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>22524155</pmid><doi>10.1111/j.1601-0825.2012.01934.x</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects barrier
cancer
clinical trial
Clinical trials
Clinical Trials as Topic
Databases, Factual
dysplasia
health education
Health Personnel - education
Humans
Leukoplakia, Oral - diagnosis
Leukoplakia, Oral - drug therapy
Mass Screening - methods
Methods
oral carcinoma
oral leukoplakia
Patient Selection
preneoplasia
referral clinic
United States
title A comparison of screening methods in two early phase oral leukoplakia clinical trials
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