Giant Cell TumorsDENONCT05542524
Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour
An observational study of Giant Cell Tumors, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Tumors
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 31 Aug 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.
Who may be able to join
- Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.
- Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed their opposition to the retrospective reuse of their data for scientific research purposes
- Pathology finally labeled other than giant cell tumour.
- Treatment with denosumab was not initiated because of death, change in treatment protocol, etc.
- Absence of oral follow-up element.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine et Chirurgie Bucco-Dentaires - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour: Retrospective Study at the University Hospitals of Strasbourg
Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult.
These tumors are found particularly in the young adult population between 20 and 40 years old, are locally aggressive, but malignant transformations and metastases (pulmonary) are quite rare.
In this study, the investigators wish to retrospectively study the oral care of patients who presented with a giant cell tumor and were treated with Denosumab at the University Hospital of Strasbourg and their associated oral follow-up
- Conditions
- Giant Cell Tumors
- Keywords
- Giant Cell Tumors, Anti-RANK-ligand antibodies
- Medical subject headings
- Giant Cell Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Decayed, Missing, and Filled Permanent Teeth (DMFT)
Measured: Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Sep 2022
- Primary completion30 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542524
- Sponsor's protocol ID
- 8699
- Acronym
- DENO
- Status last verified
- Dec 2023
- First submitted
- 12 Sep 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour: Retrospective Study at the University Hospitals of Strasbourg
- ClinicalTrials.gov ID
- NCT05542524
- Acronym / sponsor ID
- DENO / 8699
- Conditions
- Giant Cell Tumors
- Keywords
- Giant Cell Tumors, Anti-RANK-ligand antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 15 Sep 2022 (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.
Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult.
These tumors are found particularly in the young adult population between 20 and 40 years old, are locally aggressive, but malignant transformations and metastases (pulmonary) are quite rare.
In this study, the investigators wish to retrospectively study the oral care of patients who presented with a giant cell tumor and were treated with Denosumab at the University Hospital of Strasbourg and their associated oral follow-up
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.
Key inclusion criteria (2 listed)
- Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.
- Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.
Key exclusion criteria (4 listed)
- Subject having expressed their opposition to the retrospective reuse of their data for scientific research purposes
- Pathology finally labeled other than giant cell tumour.
- Treatment with denosumab was not initiated because of death, change in treatment protocol, etc.
- Absence of oral follow-up element.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Decayed, Missing, and Filled Permanent Teeth (DMFT)
Time frame: Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined
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 13 Dec 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 Giant Cell Tumors, run by University Hospital, Strasbourg, France at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 13 Dec 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 France. 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?
Number of Decayed, Missing, and Filled Permanent Teeth (DMFT) (time frame: Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined). 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 13 Dec 2023.