Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis

Официальное название

A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis

Обзор

Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.

Подробное описание

Data will be prospectively collected from at least 300 patients with acquired segmental mandibular defects of 2 cm or larger following resection of tumors or necrotic/infected tissue, all of whom require mandibular reconstruction.

The follow up (FU) will consist of standard of care (routine) procedures and data collection will be done at 3, 6, 12, 18 and up to 24 months after resection and/or reconstruction. The maximum FU for each patient within the registry will be 2 years after mandibular resection.

Data collection will include confounding baseline data, tumor characteristics, neurological function, patient reported outcomes, quality of life as well as anticipated procedure-related adverse events (AEs). Available images will be collected and evaluated centrally to determine the location, positioning, osseointegration, bone quantity and quality of the transplants.

Depending on the volume and quality of the collected data, different statistical analyses will be performed. Exploratory analyses will be conducted to find relationships between the different treatment modalities and their outcomes.

Вмешательства

• Процедура Surgical Resection and Reconstruction
  One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction. Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.

Первичные конечные точки

• Demographics [Срок оценки: Baseline until resection surgery approximately 4 weeks]
• Comorbidities [Срок оценки: Baseline until resection surgery approximately 4 weeks]
• Nicotine consumption [Срок оценки: Baseline until resection surgery approximately 4 weeks]
• Patient reported outcome: Oral Health Impact Profile (OHIP) [Срок оценки: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months]
• Difference of tumor locations of the oral squamous cell cancer [Срок оценки: Baseline until resection surgery ( approximately 4 weeks)]
• Difference of tumor staging according to the TNM system [Срок оценки: Baseline until resection surgery ( approximately 4 weeks)]
• Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages [Срок оценки: Day of resection surgery until day of reconstruction surgery up to 18 months]
• Difference of surgical procedures of osseous reconstruction [Срок оценки: Day of resection surgery until day of reconstruction surgery up to 18 months]
• Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used [Срок оценки: Day of resection surgery until day of reconstruction surgery up to 18 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Германия · 8 центров

• Universitätsklinikum Tübingen — Tübingen
• University Hospital RWTH Aachen — Aachen
• University Hospital Charité — Berlin
• Hannover Medical School — Hanover
• Universitätsklinikum Heidelberg — Heidelberg
• University Hospital Leipzig — Leipzig
• Klinikum der LMU München — Munich
• University Hospital Ulm — Ulm

США · 5 центров

• University of Florida College of Medicine — Jacksonville
• University of Illinois Chicago — Chicago
• Northwell Health Cancer Institute — New Hyde Park
• Mount Sinai Hospital — New York
• John Peter Smith Health Network — Fort Worth

Япония · 1 центр

• Shimane University — Izumo

Нидерланды · 1 центр

• Erasmus University Medical Centre — Rotterdam

Португалия · 1 центр

• Luz Hospital — Lisbon

Испания · 1 центр

• 12 de Octubre — Madrid

Швеция · 1 центр

• Uppsala University Hospital — Uppsala

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT04098146 · SMDR Registry

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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