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

R. R. Rosas, K. A. Cole, L. Darrah, Michael D Rohrer, Nelson L Rhodus, Frank G Ondrey

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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 5years. 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.

Original languageEnglish (US)
Pages (from-to)720-723
Number of pages4
JournalOral Diseases
Volume18
Issue number7
DOIs
StatePublished - Oct 1 2012

Fingerprint

Oral Leukoplakia
Clinical Trials
Leukoplakia
Databases
Medical Records
Teaching
Communication
Delivery of Health Care
Professional Education
Carcinoma
Biopsy

Keywords

  • Barrier
  • Cancer
  • Clinical trial
  • Dysplasia
  • Health education
  • Oral carcinoma
  • Oral leukoplakia
  • Preneoplasia
  • Referral clinic

Cite this

A comparison of screening methods in two early phase oral leukoplakia clinical trials. / Rosas, R. R.; Cole, K. A.; Darrah, L.; Rohrer, Michael D; Rhodus, Nelson L; Ondrey, Frank G.

In: Oral Diseases, Vol. 18, No. 7, 01.10.2012, p. 720-723.

Research output: Contribution to journalArticle

Rosas, R. R. ; Cole, K. A. ; Darrah, L. ; Rohrer, Michael D ; Rhodus, Nelson L ; Ondrey, Frank G. / A comparison of screening methods in two early phase oral leukoplakia clinical trials. In: Oral Diseases. 2012 ; Vol. 18, No. 7. pp. 720-723.
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