Oral Cancer Screening for Early Detection of Premalignant Disorders (PMOD)

NCT05296941 | Recruiting

• 1 other identifier: Public dental care
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mouth Neoplasms

Keywords

oral cancer; potentially malignant disorders; leukoplakia; erythroplakia; oral lichen planus

Outcome Measures

Primary Outcomes (1)

• Numbers of cancers diagnosed by brush sampling

  5 years

Study Arms (2)

Brush biopsy

EXPERIMENTAL

Brusch biopsy at baseline and at 3 or 6 months

Procedure: Brush sampling

Care as usual

ACTIVE COMPARATOR

Control at 3 or 6 month, surgical biopsy when needed

Procedure: Brush sampling

Interventions

Brush sampling PROCEDURE

Brush sampling instead of surgical biopsy for control of reaccurance

Brush biopsy; Care as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons 18 years of age or older who have the clinical diagnosis of leukoplakia, erythroplakia or proliferative verrukös leukoplakia

You may not qualify if:

• People who cannot read and understand information in Swedish.
• Ongoing chemotherapy and/or radiotherapy.

Sponsors & Collaborators

• Dalarna County Council, Sweden: lead
• Uppsala University: collaborator

Study Sites (1)

Kristina Edman

Falun, Dalarna County, 79129, Sweden

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms; Leukoplakia; Erythroplasia; Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Precancerous Conditions; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Public dental care

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Edman, PhD

CONTACT

+46(0)70 5349476; kristina.edman@regiondalarna.se

Jan-Michael Hirsch

CONTACT

jan.hirsch@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 25, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

SE (1)