Registry for patients with mandibular defects after cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect data from at least 300 patients who have acquired segmental mandibular defects of 2 cm or larger due to the removal of oral tumors or drug-induced osteonecrosis. Participants will undergo standard care follow-ups at various intervals up to 24 months post-surgery. The study will gather comprehensive data on tumor characteristics, neurological function, patient-reported outcomes, and potential adverse events related to the reconstruction procedures. Statistical analyses will be performed to explore relationships between treatment modalities and their outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The study includes patients with an initial pathological/histologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.
* Age 18 years and older
* Bisphosphonate related osteonecrosis of the mandible
* Immunomodulatory drugs induced mandibular osteonecrosis
* Patients presented with ameloblastoma affecting the mandible
* Patients presented with osteosarcomas of the mandible
* Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney
* Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm
* Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach
* Informed consent obtained, ie:

  * Ability to understand the content of the patient information/ICF
  * Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB/EC approved ICF OR
  * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide to provide independent written informed consent

Exclusion Criteria:

* Tumors affecting the condyle
* Patients under palliative care
* Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures

Intraoperative exclusion criteria:

* Nonsegmental mandibular defect (eg. box resection/partial resection)
* Segmental mandibular defect of less than 2 cm
* Mandibular defects extending beyond the sigmoid notch into the condyles

Additional exclusion criterion:

• No osseous reconstruction with autologous bone performed within 18 months from resection

Where it's running

• University of Florida College of Medicine
  Jacksonville, Florida, United States Recruiting
• University of Illinois Chicago
  Chicago, Illinois, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting
• John Peter Smith Health Network
  Fort Worth, Texas, United States Recruiting
• Universitätsklinikum Tübingen
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• University Hospital RWTH Aachen
  Aachen, Germany Recruiting

Study contacts

• Principal investigator: Rüdiger Zimmerer, PD, MD — University of Leipzig
• Study coordinator: Maria Medina Giner
• Email: maria.medinaginer@aofoundation.org
• Phone: 0795456120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.