CancerNCT02742363
Long Term Dental Effects in Adolescents Who Were Treated for Cancer in Childhood
An observational study of Cancer, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The investigators aim is to explore associations between specific types of cancer therapy, age at treatment and the presence of dental abnormalities in adolescence. The study will help identify unique dental changes, malformations and or missing teeth that appear in adolescence as a secondary complication due to… Read more about this study
- Who is it for?
- Ages 12 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Collecting data
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 1 Mar 2021
- Phase
- Observational
- 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 12 to 32 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old. The maximum time span of entering the study group-up to 20 years after last session of oncology treatment.
Who may be able to join
- were treated for Cancer at the age of 0-10 years old
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Oral and Dental Effects in Adolescents Who Were Treated for Cancer in Childhood
The investigators aim is to explore associations between specific types of cancer therapy, age at treatment and the presence of dental abnormalities in adolescence.
The study will help identify unique dental changes, malformations and or missing teeth that appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy and or radiotherapy) given in childhood.
Read more
Materials and methods:
- Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old.
- The following data will be collected: Demographic information, Medical Status, Cancer therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic examination.
- Conditions
- Cancer
- Being tested
- Collecting data
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting dataOther
Collecting data from patient records
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral abnormalities associated with cancer therapy.
A medical survey will be filled out with the patient and his legal guardian. A full dental examination will gather all clinical and radiographic findings. The following measures will be noted:
- Description of chemotherapy agents and duration
- Radiotherapy continuation.
- Radiotherapy dosage in Gray units.
- Yes/No questions regarding previous dental trauma.
- Yes/No questions regarding previous dental treatment.
- Questions regarding oral hygiene.
- Questions concerning oral habits.
- Extra oral examination.
- Intra oral clinical findings will be listed by tooth number.
- Radiographic findings will be listed by tooth number.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start1 Jan 2018
- Primary completion1 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742363
- Sponsor's protocol ID
- 0004-16-HMO-CTIL
- Status last verified
- Jan 2023
- First submitted
- 23 Mar 2016
- Last updated
- 20 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Oral and Dental Effects in Adolescents Who Were Treated for Cancer in Childhood
- ClinicalTrials.gov ID
- NCT02742363
- Acronym / sponsor ID
- 0004-16-HMO-CTIL
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 19 Apr 2016 (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.
The investigators aim is to explore associations between specific types of cancer therapy, age at treatment and the presence of dental abnormalities in adolescence.
The study will help identify unique dental changes, malformations and or missing teeth that appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy and or radiotherapy) given in childhood.
Materials and methods:
- Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old.
- The following data will be collected: Demographic information, Medical Status, Cancer therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic examination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old. The maximum time span of entering the study group-up to 20 years after last session of oncology treatment.
Key inclusion criteria (1 listed)
- were treated for Cancer at the age of 0-10 years old
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Collecting dataCollecting data from patient records | Other | – |
Primary outcome
Oral abnormalities associated with cancer therapy.
Time frame: Two years
A medical survey will be filled out with the patient and his legal guardian. A full dental examination will gather all clinical and radiographic findings. The following measures will be noted: 1. Description of chemotherapy agents and duration 2. Radiotherapy continuation. 3. Radiotherapy dosage in Gray units. 4. Yes/No questions regarding previous dental trauma. 5. Yes/No questions regarding previous dental treatment. 6. Questions regarding oral hygiene. 7. Questions concerning oral habits. 8. Extra oral examination. 9. Intra oral clinical findings will be listed by tooth number. 10. Radiographic findings will be listed by tooth number.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Hadassah Medical Organization at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 20 Jan 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oral abnormalities associated with cancer therapy. (time frame: Two 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 20 Jan 2023.