Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour

NCT05542524 | Completed

• 1 other identifier: 8699
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Number of Decayed, Missing, and Filled Permanent Teeth (DMFT)

  Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Médecine et Chirurgie Bucco-Dentaires - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Giant Cell Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

FR (1)