Protocol Full Title retrospective trial:

Predictive model of risk factors for long-term overall survival for oral oncology patients

Protocol Acronym/short title:

FFLED

Version and date of final protocol:

Version. 1. 09/09/2019

Sponsor:
No sponsor acquired

Principal Investigator:
Name: Michel Billa
Address: Oral & Maxillofacial Surgery, OMFS-IMPATH research group, Campus Sint-Rafael,
Kapucijnenvoer 33, 3000 Leuven
Telephone: +32 16 33 24 35
Fax: /
Email: Michel.bila@uzleuven.be

Sub-investigator:
Name: Jeroen Van Dissel
Address: Oral & Maxillofacial Surgery, OMFS-IMPATH research group, Campus Sint-Rafael,
Kapucijnenvoer 33, 3000 Leuven
Telephone: +32 16 34 57 53
Fax:/
Email: jeroen.vandessel@kuleuven.be

Name: Hongyang Ma
Address: Oral & Maxillofacial Surgery, OMFS-IMPATH research group, Campus Sint-Rafael,
Kapucijnenvoer 33, 3000 Leuven
Telephone: +32 486 495 457
Fax:/
Email: Hongyang.ma@kuleuven.be

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Signatures

_________________________ ____________________
Principal Investigator Date

Print Name:

_________________________ ____________________
Date

Print Name:

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Table of Contents
1. Background and rationale ............................................................................................................... 4
2. Trial objectives and Design .............................................................................................................. 4
3.1 Trial objectives........................................................................................................................... 4
3.2 Primary endpoints ..................................................................................................................... 4
3.3 Secondary endpoints ................................................................................................................. 4
3. Selection and withdrawal of subjects ............................................................................................. 4
3.1 Inclusion criteria ........................................................................................................................ 4
3.2 Exclusion criteria ....................................................................................................................... 5
4. Direct access to source data and documents.................................................................................. 5
5. Ethics and regulatory approvals ...................................................................................................... 5
6. Data Handling .................................................................................................................................. 6
7. Data Management........................................................................................................................... 6
8. Publication Policy ............................................................................................................................ 6
9. Financial Aspects ............................................................................................................................. 7
10. References ................................................................................................................................... 7

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1. Background and rationale

2. Trial objectives and Design

2.1 Trial objectives
This study will collect the oral oncology patients’ data and all the radiographic examination images in
our department of Maxillofacial Surgery and then retrospectively find the risk factors among all the
parameters form the database. After that, the overall survival rate by year, recurrence rate and
surgical successful rate will be calculated. Furthermore, we will find the correlations between the
outcomes and risk factors and make a protective model to anticipate all the related rate. Our findings
will provide more insight to the clinicians and surgeon to choose comprehensive treatment method
and help patients to avoid potential oral oncological susceptibility factors.

2.2 Primary endpoints

Retrospectively collect all the oral oncology patients survival rate, flap success rate and tumor
recurrence rate, then risk factors will be confirmed.

Predictive model will be established and displayed in nomogram in order that people can directly
know the oral oncology patients’ prognosis.

2.3 Secondary endpoints

Prognostic model will be validated internally and externally to verify its feasibility and then calibrate
its accuracy.

Investigations of impact on decision making and patient outcomes will be concluded and discussed.

3. Selection and withdrawal of subjects

3.1 Inclusion criteria

Patients diagnosed with oral oncology, surgically treated at our department of Maxillofacial Surgery,
University Hospital of Leuven will be included. Underlying conditions include: all types of head and
neck benign and malignant tumor.
The treatment included surgical resection
The inclusion period is from 01/01/1993 until 31/12/2018
Patients of all ages and sex will be included

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This section should contain details of age, sex, disease, prior treatment constraints etc., under which
a subject is deemed to be suitable (eligible) to participate in the trial. This also includes healthy
volunteers and any “control” groups etc. Each such “group” should be defined separately. Informed
consent to participate must be stated as an inclusion criterion. A simple list format is the preferred
style. It should be stated if women of child bearing age will be included or excluded and suitable
methods of contraception to enable inclusion into the trial.

3.2 Exclusion criteria

Patients undergone surgery in other centers
Patients with non-primary head and neck tumor

This section should contain details of age, sex, disease, prior treatment constraints etc., under which
a subject is considered to be unsuitable for inclusion into the study population. (Examples frequently
include exposure to prior radiotherapy in cancer trials, and participation in a trial with an
investigational product within the previous three months in pharmacokinetics trials). It should be
stated if women of child bearing age will be included or excluded and suitable methods of
contraception to enable inclusion into the trial. A simple list format is the preferred style.

4. Direct access to source data and documents

It will be specified, (or reference is made to another written agreement) that the investigator(s) and
the institution(s) will permit trial-related monitoring, audits, EC review, and regulatory inspections
(where appropriate) by providing direct access to source data and other documents (ie patients’ case
sheets, blood test reports, X-ray reports, histology reports etc).

5. Ethics and regulatory approvals

A statement that the trial will be conducted in compliance with the principles of the Declaration of
Helsinki (specifying which amendment), the principles of GCP and all of the applicable regulatory
requirements (specify current legislation) is essential. State the name and address of the EC to which
the study protocol and other documentation will be submitted. You should also state that any
subsequent protocol amendments will submitted to the EC for approval,

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E.g.

The trial will be conducted in compliance with the principles of the Declaration of Helsinki (current
version), the principles of GCP and in accordance with all applicable regulatory requirements. This
protocol and related documents will be submitted for review to Ethics Committee.

The Investigator and the Participating Site shall treat all information and data relating to the Study
disclosed to Participating Site and/or Investigator in this Study as confidential and shall not
disclose such information to any third parties or use such information for any purpose other than
the performance of the Study. The collection, processing and disclosure of personal data, such as
patient health and medical information is subject to compliance with applicable personal data
protection and the processing of personal data (Directive 95/46/EC and Belgian law of December
8, 1992 on the Protection of the Privacy in relation to the Processing of Personal Data)

Data are anonymous if no one, not even the researcher, can connect the data to the individual
who provided it. No identifying information is collected from the individual.
When data are coded, there continues to be a link between the data and the individual who
provided it. The research team is obligated to protect the data from disclosure outside the
research according to the terms of the research protocol and the informed consent document.
The subject’s name or other identifiers should be stored separately (site file) from their research
data and replaced with a unique code to create a new identity for the subject. Note that coded
data are not anonymous.

6. Data Handling

7. Data Management
Give details of whether paper or electronic CRF will be used, describe the proposed database etc

8. Publication Policy

E.g in case of multicentre trial:

It is anticipated that the results of the overall Study shall be published in a multi-centre publication,
involving the data of all clinical sites participating in the Study.
Participating Site is not allowed to publish any data or results from the Study prior to the multicentre
publication, provided however that Participating Site is allowed to publish the results generated at the

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Participating Site if the multicentre publication has not occurred after 12 months from Study database
lock.
Any publication by Participating Site will be submitted to the Sponsor for review at least thirty (30)
days prior to submission or disclosure. Sponsor shall have the right to delay the projected publication
for a period of up to three (3) months from the date of first submission to the Sponsor in order to
enable the Sponsor to take steps to protect its intellectual property rights and know-how.

Publications will be coordinated by the Investigator of Sponsor. Authorship to publications will be

determined in accordance with the requirements published by the International Committee of Medical
Journal Editors and in accordance with the requirements of the respective medical journal.

9. Financial Aspects

10. References

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