Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098146
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
AO Innovation Translation Center ( AO Clinical Investigation and Documentation )

Brief Summary:
Prospective 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.

Condition or disease Intervention/treatment
Mandibular Reconstruction Procedure: Surgical Resection and Reconstruction

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: International, Multicenter, Prospective Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction (SMDR) Following Oral Squamous Cell Carcinoma (OSSC) Resection
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


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
Procedure: 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.





Primary Outcome Measures :
  1. Demographics [ Time Frame: Baseline until resection surgery approximately 4 weeks ]
    Demographics (year of birth, height in cm and weight in kilogram, race)

  2. Comorbidities [ Time Frame: Baseline until resection surgery approximately 4 weeks ]
    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

  3. Nicotine consumption [ Time Frame: Baseline until resection surgery approximately 4 weeks ]

    Current and previous nicotine use will be collected:

    • Number of years
    • Time (years) since stopped using (if applicable)
    • Amount of cigarettes/day

  4. Patient reported outcome: Oral Health Impact Profile (OHIP) [ Time Frame: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months ]

    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.


  5. Difference of tumor locations of the oral squamous cell cancer [ Time Frame: Baseline until resection surgery ( approximately 4 weeks) ]

    Oral squamous cell carcinoma locations acoording to follwoing regions:

    • Anterior compartment which includes lower lip, buccal mucosa, anterior vestibule, anterior ridge and anterior floor mouth
    • Lateral compartment which includes posterior vestibule, posterior alveolar ridge, posterior (lateral) floor of mouth
    • Retromolar compartment which includes alveolar ridge posterior to last molar, region of wisdom teeth, retromolar triangle ie buccal cheek, soft palate (arch), tonsillar regions
    • Tongue which includes ventral tongue (undersurface of tongue), lateral rim of tongue, base of tongue

  6. Difference of tumor staging according to the TNM system [ Time Frame: Baseline until resection surgery ( approximately 4 weeks) ]

    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.


  7. 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 ]
    • Duration of surgery (skin to skin) in minutes
    • Length of hospital stay in days
    • Date of osseous reconstruction (if different from resection surgery) in days

  8. Difference of surgical procedures of osseous reconstruction [ Time Frame: Day of resection surgery until day of reconstruction surgery up to 18 months ]
    • Numers of Bone and soft tissue flaps to reconstruct the mandible: ie number of pieces in which the donor bone(s) is cut to shape the reconstructed mandible
    • Type of bone donor/ bone transfer site(s): Vascularized bone flap(s) or composite flaps (ie bone and adjacent soft tissue harvested within the same flap) and type(s)

  9. 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 ]
    • Use of virtual surgical planning (VSP) for resection: Yes/No.
    • Only virtual planning and simulation of resection (no 3D printing):Yes/No.
    • 3D-printed biomodels: Yes/No



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients presenting with an acquired segmental mandibular defect secondary to oral squamous cell carcinoma removal and who require mandibular reconstruction.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098146


Contacts
Layout table for location contacts
Contact: Joffrey Baczkowski +41 44 200 24 31 joffrey.baczkowski@aofoundation.org

Sponsors and Collaborators
AO Clinical Investigation and Documentation
Layout table for additonal information
Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT04098146    
Other Study ID Numbers: SMDR_RP_v1.0
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell