Chemotherapy EffectNCT06517927
Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10
A study testing Clinical and radiographic dental examination in people with Chemotherapy Effect and Dental Caries, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To date, there are no methods for assessing the risk of oral developmental defects that could predict long-term adverse effects in childhood cancer survivors. Having such a method at our disposal would enable us to better assess the risk to develop those defects and will help us provide new prevention and treatment… Read more about this study
- Who is it for?
- Ages 12 to 36 years
- Conditions the study is for
- Chemotherapy Effect, Dental Caries, Malocclusion
- What is being tested?
- Clinical and radiographic dental examination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteBelgium
- Study dates
- 3 May 2024to 3 May 2026
- 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 12 to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age below 10 at cancer diagnosis (for the CCS group).
- Chemotherapy must have been used to treat the patient (For the CCS group).
- The patient is 12 years old or older at the time of the follow-up appointment of the present study
Who cannot join
- A patient who was diagnosed and treated after 10 years old.
- Patient below 12 years old at time of study recruitment
- Patients with syndrome or diseases that involve teeth impairment*
- Pregnant patient
- Refusal or inaptitude to undergo dental and radiographic examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Maëlle De Ville de Goyet, maelle.deville@saintluc.uclouvain.be
About this study
To date, there are no methods for assessing the risk of oral developmental defects that could predict long-term adverse effects in childhood cancer survivors. Having such a method at our disposal would enable us to better assess the risk to develop those defects and will help us provide new prevention and treatment strategies to ensure a healthy oral development.
The aims of this study are :
- Assess the caries risk in childhood cancer survivors compared with a control group.
- Assess the dental development defects risk in childhood cancer survivors compared with a control group.
Read the detailed description
This will be an international study comparing the Childhood Cancer Survivors (CCS) and a control group.
A questionnaire will be provided to the patients to gather information. A standard of care dental examination will then take place in a dental office in the Cliniques Universitaires Saint-Luc. We also collect medical data to complete the files.
- Conditions
- Chemotherapy Effect, Dental Caries, Malocclusion, Childhood Cancer, Tooth Defect
- Being tested
- Clinical and radiographic dental examination
- Keywords
- Childhood cancer survivors, Dental defect
- Medical subject headings
- Dental Caries, Malocclusion, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and radiographic dental examinationDiagnostic test
complete clinical oral examination + intra-oral and panoramic x-rays
| Study group | Role | What they receive |
|---|---|---|
| Cancer survivor | Experimental | Not described Receives: Diagnostic Test: Clinical and radiographic dental examination |
| Control | Active comparator | Not described Receives: Diagnostic Test: Clinical and radiographic dental examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the caries experience by using the Decay Missing Filled Teeth score (DMFT)
Assess the impact of the chemotherapy agents on the risk of ulterior caries development
Measured: Thoughout the entire study, approximately during 2 years
Secondary outcomes (1)
Assessment of the prevalence of dental development defects (DDD)
Assess the impact of the chemotherapy agents on the risk of ulterior dental development defect
Measured: Thoughout the entire study, approximately during 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start3 May 2024
- Primary completion3 May 2026 (estimated)
- Study completion3 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventionnal study, cohort study
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maëlle De Ville de Goyet, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517927
- Sponsor's protocol ID
- DENTAL CHEMO
- Status last verified
- Nov 2024
- First submitted
- 18 Jul 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10
- ClinicalTrials.gov ID
- NCT06517927
- Acronym / sponsor ID
- DENTAL CHEMO
- Conditions
- Chemotherapy Effect, Dental Caries, Malocclusion, Childhood Cancer, Tooth Defect
- Keywords
- Childhood cancer survivors, Dental defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 3 May 2026 (estimated)
- Study completion
- 3 May 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- 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.
To date, there are no methods for assessing the risk of oral developmental defects that could predict long-term adverse effects in childhood cancer survivors. Having such a method at our disposal would enable us to better assess the risk to develop those defects and will help us provide new prevention and treatment strategies to ensure a healthy oral development.
The aims of this study are :
- Assess the caries risk in childhood cancer survivors compared with a control group.
- Assess the dental development defects risk in childhood cancer survivors compared with a control group.
Detailed description
This will be an international study comparing the Childhood Cancer Survivors (CCS) and a control group.
A questionnaire will be provided to the patients to gather information. A standard of care dental examination will then take place in a dental office in the Cliniques Universitaires Saint-Luc. We also collect medical data to complete the files.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventionnal study, cohort study
| Arm | Type | Receives |
|---|---|---|
| Cancer survivor | Experimental | Diagnostic Test: Clinical and radiographic dental examination |
| Control | Active comparator | Diagnostic Test: Clinical and radiographic dental examination |
Who may qualify
- Ages
- 12 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age below 10 at cancer diagnosis (for the CCS group).
- Chemotherapy must have been used to treat the patient (For the CCS group).
- The patient is 12 years old or older at the time of the follow-up appointment of the present study
Key exclusion criteria (5 listed)
- A patient who was diagnosed and treated after 10 years old.
- Patient below 12 years old at time of study recruitment
- Patients with syndrome or diseases that involve teeth impairment*
- Pregnant patient
- Refusal or inaptitude to undergo dental and radiographic examination
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 |
|---|---|---|
| Clinical and radiographic dental examinationcomplete clinical oral examination + intra-oral and panoramic x-rays | Diagnostic test | Cancer survivor, Control |
Primary outcome
Assessment of the caries experience by using the Decay Missing Filled Teeth score (DMFT)
Time frame: Thoughout the entire study, approximately during 2 years
Assess the impact of the chemotherapy agents on the risk of ulterior caries development
1 secondary outcome
Assessment of the prevalence of dental development defects (DDD)
Time frame: Thoughout the entire study, approximately during 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Maëlle De Ville de Goyet principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and radiographic dental examination in people with Chemotherapy Effect and Dental Caries, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 5 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 19 Nov 2024. 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 Belgium. 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 Armand IRAKOZE (027645741 ext. +32, armand.irakoze@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the caries experience by using the Decay Missing Filled Teeth score (DMFT) (time frame: Thoughout the entire study, approximately during 2 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 19 Nov 2024.