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Mouth NeoplasmsPMODNCT05296941

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

A study testing Brush sampling in people with Mouth Neoplasms, run by Dalarna County Council, Sweden at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mouth Neoplasms
What is being tested?
Brush sampling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSweden
Study dates
1 Aug 2023to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jan-Michael Hirsch contact

jan.hirsch@sll.se

Sweden1 site, 1 recruiting
  • Kristina Edman

    Falun, Dalarna County, 79129

    Kristina Edman, PhD, +46705349476, kristina.edman@regiondalarna.se

    Recruiting

Other trials in Sweden

About this study

Official title: Screening for Oral Cancer for Early Detection of Premalignant Disorders

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.

Read the 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.

Conditions
Mouth Neoplasms
Being tested
Brush sampling
Keywords
oral cancer, potentially malignant disorders, leukoplakia, erythroplakia, oral lichen planus
Medical subject headings
Mouth Neoplasms, Leukoplakia, Erythroplasia, Lichen Planus, Oral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brush samplingProcedure or surgery

    Brush sampling instead of surgical biopsy for control of reaccurance

Study groups in NCT05296941
Study groupRoleWhat they receive
Brush biopsyExperimentalBrusch biopsy at baseline and at 3 or 6 months
Receives: Procedure: Brush sampling
Care as usualActive comparatorControl at 3 or 6 month, surgical biopsy when needed
Receives: Procedure: Brush sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numbers of cancers diagnosed by brush sampling

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start1 Aug 2023
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05296941
Sponsor's protocol ID
Public dental care
Acronym
PMOD
Status last verified
Sep 2023
First submitted
8 Mar 2022
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Brush sampling in people with Mouth Neoplasms, run by Dalarna County Council, Sweden at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristina Edman, PhD (+46(0)70 5349476, kristina.edman@regiondalarna.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbers of cancers diagnosed by brush sampling (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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