Oral Cancer Screening for Early Detection of Premalignant Disorders (PMOD) (PMOD)
Primary Purpose
Mouth Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Brush sampling
Sponsored by
About this trial
This is an interventional prevention trial for Mouth Neoplasms focused on measuring oral cancer, potentially malignant disorders, leukoplakia, erythroplakia, oral lichen planus
Eligibility Criteria
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.
Sites / Locations
- Kristina EdmanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brush biopsy
Care as usual
Arm Description
Brusch biopsy at baseline and at 3 or 6 months
Control at 3 or 6 month, surgical biopsy when needed
Outcomes
Primary Outcome Measures
Numbers of cancers diagnosed by brush sampling
Secondary Outcome Measures
Full Information
NCT ID
NCT05296941
First Posted
March 8, 2022
Last Updated
September 6, 2023
Sponsor
Dalarna County Council, Sweden
Collaborators
Uppsala University
1. Study Identification
Unique Protocol Identification Number
NCT05296941
Brief Title
Oral Cancer Screening for Early Detection of Premalignant Disorders (PMOD)
Acronym
PMOD
Official Title
Screening for Oral Cancer for Early Detection of Premalignant Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalarna County Council, Sweden
Collaborators
Uppsala University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cancer is a complex disease; its different causes and types have a strong impact on patient treatment and prognosis. To improve understanding of the disease, its causes and progression, the investigators will develop a simple, cost-effective system for continuous control of mucosal lesions with non-invasive brush biopsy that can be managed in primary dental care, as an alternative to tissue biopsy in order to reduce the number of oral cavity cancers.
Detailed Description
In Sweden, about 1,200 cases of cancer of the oral cavity, lips and throat are diagnosed each year. This is significantly higher than the global age-standardized incidence of 6.1 per 100,000 inhabitants, including all ages and genders. Oral cancer is a serious and growing public health problem and leads to significantly reduced quality of life after extensive treatment that usually includes radiation therapy and surgery. Patients often have pain, swallowing problems, dry mouth that causes tooth status, negatively affected appearance, family life and social interaction. Although it is well known that early diagnostic screening is of great importance for increasing survival, there is a lack of a nationally organized screening program of high-risk individuals, tobacco users and individuals with overconsumption of alcohol. As a result, many cases are diagnosed late and therefore have poor prognosis. The five-year survival rate in Sweden for the diagnosis of oral cancer is about 60%. If the tumor is small when diagnosed, without lymph node involvement or metastases,and treated correctly, a survival rate of 90% can be achieved while in a late diagnosis with the presence of lymph node involvement and metastases, survival drops drastically and is only 36%. A large proportion of oral cancer originates from potentially malignant oral mucosal lesions (PMOD) that occur in a prevalence of about 2-3% globally and over time are at risk of malignification. Of PMOD, oral leukoplakia (OL) is the most prevalent and most common in the group of middle-aged or older men. Swedish prevalence figures for OL have been reported to range from 0.7% to 3.5%. As patients with PMOD such as OL, erythroplakia (EP) or proliferative verrukös are at a significantly increased risk of developing oral cancer, it is important to include these patients in a functioning control system. This is especially true for risk individuals, those with an overconsumption of alcohol, with tobacco use, and those with chronic infection of tonsil and tongue base with high-risk human papillomavirus. About 80% of the adult population in Sweden is regularly examined at private dental care or public dental care, which means that general dental care can take a great responsibility for identifying and carrying out continuous checks on risk groups. A routine examination of the patient should include assessment of the oral mucosa according to clinical practice. Oral mucosal changes should be diagnosed and, if necessary, treatment initiated. In the case of a clinical diagnosis of OL, EP or verrukös leukoplakia, the clinical diagnosis should be verified with a tissue biopsy performed at a specialist clinic in orofacial medicine, oral surgery or ear-nose-throat clinic. Based on the diagnosis and degree of cell changes, it is decided according to current practice whether the continued treatment and the patient is included in a system for continuous checks. Oral cancer must be diagnosed early because mortality is high, especially in late diagnosis, and quality of life after treatment is very poor with significant pain, speech, chewing and swallowing difficulties with a strong impact on both family life and social contacts and working life. The solution is early detection and early treatment, which can be achieved if follow-up are performed in primary dental care with non-invasive brush biopsies for cytological diagnostics in a similar way to cervical cancer screening managed by midwives. Cytological diagnosis of oral mucosal changes is a safe, simple and rapid method with high sensitivity and specificity. With the present series of studies, the investigators intend to evaluate different possibilities to identify PMOD with high-grade dysplasias, and tumors early in order to improve prognosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth Neoplasms
Keywords
oral cancer, potentially malignant disorders, leukoplakia, erythroplakia, oral lichen planus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brush biopsy
Arm Type
Experimental
Arm Description
Brusch biopsy at baseline and at 3 or 6 months
Arm Title
Care as usual
Arm Type
Active Comparator
Arm Description
Control at 3 or 6 month, surgical biopsy when needed
Intervention Type
Procedure
Intervention Name(s)
Brush sampling
Intervention Description
Brush sampling instead of surgical biopsy for control of reaccurance
Primary Outcome Measure Information:
Title
Numbers of cancers diagnosed by brush sampling
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Edman, PhD
Phone
+46(0)70 5349476
Email
kristina.edman@regiondalarna.se
First Name & Middle Initial & Last Name or Official Title & Degree
Jan-Michael Hirsch
Email
jan.hirsch@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Public dental care
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kristina Edman
City
Falun
State/Province
Dalarna
ZIP/Postal Code
79129
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Edman, PhD
Phone
+46705349476
Email
kristina.edman@regiondalarna.se
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Oral Cancer Screening for Early Detection of Premalignant Disorders (PMOD)
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