- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04098146
Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection
International, Multicenter, Prospective Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction (SMDR) Following Oral Squamous Cell Carcinoma (OSSC) Resection
Study Overview
Status
Intervention / Treatment
Detailed Description
Prospective data will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Felix Thomas, PhD
- Phone Number: + 41 79 671 47 98
- Email: felix.thomas@aofoundation.org
Study Contact Backup
- Name: Alix Frischknecht, M.sc.
- Email: alix.frischknecht@aofoundation.org
Study Locations
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Aachen, Germany, 52074
- Recruiting
- University Hospital RWTH Aachen
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Contact:
- Ali Modabber, Prof
- Phone Number: +49 241 80 88258
- Email: Amodabber@ukaachen.de
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Berlin, Germany, 13353
- Recruiting
- University Hospital Charité
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Contact:
- Max Heiland, Prof
- Phone Number: +49 450 655 270
- Email: Max.Heiland@charite.de
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Hannover, Germany, 30625
- Recruiting
- Hannover Medical School
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Contact:
- Philippe Korn, PD, MD
- Phone Number: +49 511 532 4879
- Email: korn.philippe@mh-hannover.de
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Heidelberg, Germany, 69120
- Recruiting
- Universitätsklinikum Heidelberg
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Contact:
- Christian Freudlsperger, Prof
- Phone Number: +49 6221 56 34444
- Email: Christian.Freudlsperger@med.uni-heidelberg.de
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Leipzig, Germany, 04103
- Recruiting
- University Hospital Leipzig
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Contact:
- Tabea Pankow, PD, MD
- Phone Number: + 49 3419721863
- Email: tabea.pankow@medizin.uni-leipzig.de
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Munich, Germany, 80337
- Recruiting
- Klinikum der LMU München
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Contact:
- Wenko Smolka, PD, MD
- Phone Number: +49 440054458
- Email: Wenko.Smolka@med.lmu.de
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Baden-Württemberg
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Tübingen, Baden-Württemberg, Germany, 72076
- Not yet recruiting
- Universitätsklinikum Tübingen
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Contact:
- Andreas Naros, MD
- Phone Number: +49 7071 2986174
- Email: andreas.naros@med.uni-tuebingen.de
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Rotterdam, Netherlands, 3015 GD
- Not yet recruiting
- Erasmus University Medical Centre
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Contact:
- Eppo Wolvius, Prof
- Phone Number: +31 6 22 48 77 81
- Email: E.Wolvius@erasmusmc.nl
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Madrid, Spain, 28041
- Recruiting
- 12 de Octubre
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Contact:
- Maria Mejía Nieto, MD
- Phone Number: +34 687 083 530
- Email: Mmejianieto@hotmail.com
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Uppsala, Sweden, 75185
- Not yet recruiting
- Uppsala University Hospital
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Contact:
- Andreas Thor, Prof
- Phone Number: +46 18 6116450
- Email: Andreas.Thor@akademiska.se
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Basel, Switzerland, 4031
- Not yet recruiting
- University Hospital Basel
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Contact:
- Florian Thieringer, MD
- Phone Number: +41 612 657 344
- Email: Florian.Thieringer@usb.ch
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Florida
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Jacksonville, Florida, United States, 32209
- Recruiting
- University of Florida College of Medicine
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Contact:
- Rui Fernandes, Prof
- Phone Number: 904-244-3901
- Email: Rui.Fernandes@jax.ufl.edu
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Texas
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Fort Worth, Texas, United States, 76104
- Not yet recruiting
- John Peter Smith Health Network
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Contact:
- Roderick Kim, MD
- Phone Number: 817-702-6979
- Email: roderickykim@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years and older
- Initial pathologically confirmed diagnosis of primary oral squamous cell carcinoma located in mucosa and/or mandible
- Undergoing primary curative treatment with segmental resection of the mandible ≥4 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)
- Signed and dated IRB/EC approved informed consent (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
- Distant OSCC metastasis
- Any other active concomitant malignancy within the last 5 years
- Patients who require neoadjuvant therapy
- Patients under palliative care
- Previous extensive mandibular surgeries (including reconstructions)
Intraoperative exclusion criteria:
- Nonsegmental mandibular defect (eg. box resection/partial resection)
- Segmental mandibular defect of less than 4 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mandibular Reconstruction
Patients undergoing segmental mandibular defect reconstruction.
The decision of one stage or two stage reconstruction is done according to the patient and treating surgeon preferences following the local standard of care
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics
Time Frame: Baseline until resection surgery approximately 4 weeks
|
Demographics (year of birth, height in cm and weight in kilogram, race)
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Baseline until resection surgery approximately 4 weeks
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Comorbidities
Time Frame: Baseline until resection surgery approximately 4 weeks
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Comorbidities assessed by Charlson Comorbidity Index (this score assesses the comorbidity level by considering both the number and severity of predefined comorbidity conditions.
It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates
|
Baseline until resection surgery approximately 4 weeks
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Nicotine consumption
Time Frame: Baseline until resection surgery approximately 4 weeks
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Current and previous nicotine use will be collected:
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Baseline until resection surgery approximately 4 weeks
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Patient reported outcome: Oral Health Impact Profile (OHIP)
Time Frame: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months
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Change in the OHIP over the follow-up period. The Oral Health Impact Profile is providing a comprehensive measure of self-reported dysfunction, discomfort and disability attributed to oral conditions. The OHIP is concerned with impairment and three functional status dimensions (social, psychological, and physical). Respondents are asked to indicate on a five-point Likert scale how frequently they experienced each problem. Response categories for the five-point scale are: "Very often", "Fairly often", "Occasionally", "Hardly ever" and "Never". The OHIP consists of 14 questions in which higher scores indicate worse outcomes. |
Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months
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Difference of tumor locations of the oral squamous cell cancer
Time Frame: Baseline until resection surgery ( approximately 4 weeks)
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Oral squamous cell carcinoma locations acoording to follwoing regions:
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Baseline until resection surgery ( approximately 4 weeks)
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Difference of tumor staging according to the TNM system
Time Frame: Baseline until resection surgery ( approximately 4 weeks)
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Oral squamous cell carcinoma staging according to TNM (Tumor, Node, Metastasis) system. In the TNM system the "T" refers to the size and extent of the main tumor likert from T0 to T4 whereas T0 is the smallest and T4 the biggest size. The main tumor is usually called the primary tumor. The "N" refers to the number of nearby lymph nodes that have cancer likert for N0 to N3 whereas N0 is the single nearby lymphnode and N3 multiple lymphnodes. The "M" refers to whether the cancer has metastasized likert from M0 to M1 whereas M0 is no distant metastasis and M1 is distant metastasis. |
Baseline until resection surgery ( approximately 4 weeks)
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Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages
Time Frame: Day of resection surgery until day of reconstruction surgery up to 18 months
|
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Day of resection surgery until day of reconstruction surgery up to 18 months
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Difference of surgical procedures of osseous reconstruction
Time Frame: Day of resection surgery until day of reconstruction surgery up to 18 months
|
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Day of resection surgery until day of reconstruction surgery up to 18 months
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Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used
Time Frame: Day of resection surgery until day of reconstruction surgery up to 18 months
|
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Day of resection surgery until day of reconstruction surgery up to 18 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rüdiger Zimmerer, PD, MD, University of Leipzig
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMDR Registry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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