Oral Cancer Screening for Early Detection of Premalignant Disorders (PMOD) (PMOD)
Screening for Oral Cancer for Early Detection of Premalignant Disorders
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Kristina Edman, PhD
- Phone Number: +46(0)70 5349476
- Email: kristina.edman@regiondalarna.se
Study Contact Backup
- Name: Jan-Michael Hirsch
- Email: jan.hirsch@sll.se
Study Locations
-
-
Dalarna
-
Falun, Dalarna, Sweden, 79129
- Recruiting
- Kristina Edman
-
Contact:
- Kristina Edman, PhD
- Phone Number: +46705349476
- Email: kristina.edman@regiondalarna.se
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Persons 18 years of age or older who have the clinical diagnosis of leukoplakia, erythroplakia or proliferative verrukös leukoplakia
Exclusion Criteria:
- People who cannot read and understand information in Swedish.
- Ongoing chemotherapy and/or radiotherapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Brush biopsy
Brusch biopsy at baseline and at 3 or 6 months
|
Brush sampling instead of surgical biopsy for control of reaccurance
|
|
Active Comparator: Care as usual
Control at 3 or 6 month, surgical biopsy when needed
|
Brush sampling instead of surgical biopsy for control of reaccurance
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Numbers of cancers diagnosed by brush sampling
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Public dental care, Uppsala University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Public dental care
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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