Chromosomal InstabilityNCT02238574
Diagnostics for the Treatment of Progressive Mucosal Lesions of the Oral Cavity: a Prospective Study
A study testing surgery and follow up in people with Chromosomal Instability and Low Grade Dysplasia Oral Cavity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a 5-year survival of ~ 50%. Malignancies of the head and neck area are (almost) always preceded by precursor lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chromosomal Instability, Low Grade Dysplasia Oral Cavity, Loss of Heterozygostiy
- What is being tested?
- surgery and follow up
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Start not givento Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects ≥18 years
- premalignant lesions of the oral cavity, classified as hyperkeratosis, hyperplasia, mild or moderate dysplasia
- written informed consent
Who cannot join
- former malignancy or lesion classified as severe dysplasia or carcinoma in situ at the same anatomical localization of the oral cavity
- lesions within an anatomical field which has been exposed to former treatment (e.g. radiotherapy)
- insufficient biopsy material to perform additional FISH analysis
- pregnancy, because of the physical burden (e.g. extra general anesthesia) in this study setting
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, Limburg, 6202
About this study
Official title: Chromosomal Instability as an Indicator for the Treatment of Progressive Mucosal Lesions of the Oral Cavity.
Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a 5-year survival of ~ 50%. Malignancies of the head and neck area are (almost) always preceded by precursor lesions. Treatment of these premalignant mucosal abnormalities is generally limited and not very inconvenient for the patient. If this precursor lesion remain untreated, it may develop into a malignancy of the head and neck. Extensive treatment will be necessary. This means loss of function of the mouth, eg chewing, speaking and swallowing.
The hypothesis is that chromosomal instability (CIN) detected by fluorescence is situ hybridization (FISH) is a reliable indicator for progression to malignancy. By intensifying the follow up and treatment in premalignant CIN lesions, the incidence of progression to invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified, there will be a place for CIN detection as a risk indicator in the diagnostic work up of premalignant lesions in the head and neck.
The investigators second hypothesis is that loss of heterozygosity (LOH) detected bij DNA markers is a reliable indicator for progression to malignancy. By intensifying the outpatient clinic follow up and treatment in premalignant lesions, the incidence of progression to invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified, there will be a place for CIN and LOH detection as a risk indicator in the diagnostic work up of premalignant lesions in the head and neck.
- Conditions
- Chromosomal Instability, Low Grade Dysplasia Oral Cavity, Loss of Heterozygostiy, Fluorescence In Situ Hybridization
- Being tested
- surgery, follow up
- Medical subject headings
- Chromosomal Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
excision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity
follow upOther
Intensified outpatient follow up (16 visits in 5 years)
| Study group | Role | What they receive |
|---|---|---|
| follow up & surgery | Experimental | CIN positive with surgery and intensified follow up Receives: Procedure: surgery; Other: follow up |
| follow up | Active comparator | CIN positive, only intensified outpatient follow up Receives: Other: follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity.
The primary goal of this prospective study is:
- Demonstrating the predictive value of the detection of CIN in premalignant lesions of the oral cavity by the use of FISH for the occurrence of progression to severe dysplasia /CIS or invasive carcinoma.
- The prevention of progression of premalignant lesions of the oral cavity to severe dysplasia / CIS or invasive carcinoma by the treatment of selected high-risk lesions.
Measured: 1 year
Secondary outcomes (1)
Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.
The secondary objective of this study is as follows:
Demonstrating the predictive value of the detection of LOH in premalignant lesions of the oral cavity by the use of DNA markers for the occurrence of progression to severe dysplasia / CIS or invasive carcinoma.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Primary completionJan 2016 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosomal InstabilityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maarten Borgemeester, MD, Study director, University medical centre Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238574
- Sponsor's protocol ID
- NL46343.068.13
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromosomal Instability as an Indicator for the Treatment of Progressive Mucosal Lesions of the Oral Cavity.
- ClinicalTrials.gov ID
- NCT02238574
- Acronym / sponsor ID
- NL46343.068.13
- Conditions
- Chromosomal Instability, Low Grade Dysplasia Oral Cavity, Loss of Heterozygostiy, Fluorescence In Situ Hybridization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a 5-year survival of ~ 50%. Malignancies of the head and neck area are (almost) always preceded by precursor lesions. Treatment of these premalignant mucosal abnormalities is generally limited and not very inconvenient for the patient. If this precursor lesion remain untreated, it may develop into a malignancy of the head and neck. Extensive treatment will be necessary. This means loss of function of the mouth, eg chewing, speaking and swallowing.
The hypothesis is that chromosomal instability (CIN) detected by fluorescence is situ hybridization (FISH) is a reliable indicator for progression to malignancy. By intensifying the follow up and treatment in premalignant CIN lesions, the incidence of progression to invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified, there will be a place for CIN detection as a risk indicator in the diagnostic work up of premalignant lesions in the head and neck.
The investigators second hypothesis is that loss of heterozygosity (LOH) detected bij DNA markers is a reliable indicator for progression to malignancy. By intensifying the outpatient clinic follow up and treatment in premalignant lesions, the incidence of progression to invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified, there will be a place for CIN and LOH detection as a risk indicator in the diagnostic work up of premalignant lesions in the head and neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| follow up & surgery | Experimental | Procedure: surgery, Other: follow upCIN positive with surgery and intensified follow up |
| follow up | Active comparator | Other: follow upCIN positive, only intensified outpatient follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects ≥18 years
- premalignant lesions of the oral cavity, classified as hyperkeratosis, hyperplasia, mild or moderate dysplasia
- written informed consent
Key exclusion criteria (4 listed)
- former malignancy or lesion classified as severe dysplasia or carcinoma in situ at the same anatomical localization of the oral cavity
- lesions within an anatomical field which has been exposed to former treatment (e.g. radiotherapy)
- insufficient biopsy material to perform additional FISH analysis
- pregnancy, because of the physical burden (e.g. extra general anesthesia) in this study setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryexcision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity | Procedure or surgery | follow up & surgery |
| follow upIntensified outpatient follow up (16 visits in 5 years) | Other | follow up, follow up & surgery |
Primary outcome
Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity.
Time frame: 1 year
The primary goal of this prospective study is: 1. Demonstrating the predictive value of the detection of CIN in premalignant lesions of the oral cavity by the use of FISH for the occurrence of progression to severe dysplasia /CIS or invasive carcinoma. 2. The prevention of progression of premalignant lesions of the oral cavity to severe dysplasia / CIS or invasive carcinoma by the treatment of selected high-risk lesions.
1 secondary outcome
Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Borgemeester, MD study director
University medical centre Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery and follow up in people with Chromosomal Instability and Low Grade Dysplasia Oral Cavity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 9 Jan 2018. 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 Netherlands. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity. (time frame: 1 year). 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 9 Jan 2018.