National Cancer Institute
Cairo University
Write your title here
Protocol for M.Sc./MD thesis in Medical Oncology
Submitted by
XXXXXXXXXXXXXXXXXXXXXXXXXX
M.B.B.Ch./M.Sc.
Under supervision of
Dr. Ahmed Abdelmabood Zeeneldin
Associate professor of Medical Oncology,
National Cancer Institute,
Cairo University
Dr. XXXXXXXXXXXXXXXXXXXXX
Lecturer of Medical Oncology
National Cancer Institute,
Cairo University
Dr.
XXXXXXXXXXXXXXXXXXXXXXXXXX
Lecturer of Medical Oncology,
National Cancer Institute,
Cairo University
National Cancer Institute
Cairo University
2012
RCENCI Retrospective Protocol Template v1.0 (AZ)
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‫‪National Cancer Institute‬‬
‫‪Cairo University‬‬
‫اكتب العنوان هنا‬
‫بروتوكول دراسة توطئة للحصول علي درجة الماجستير‪/‬الدكتوراة في طب األورام‬
‫مقدمة من الطبيب‬
‫دددددددددددددددددددددددددددددددددددددددد‬
‫تحت اشراف‬
‫ا‪.‬د‪ .‬أحمد عبد المعبود زين الدين‬
‫أستاذ مساعد طب االورام‬
‫المعهد القومي لالورام‬
‫جامعة القاهرة‬
‫ددددددددددددددددددددد‬
‫مدرس طب االورام‬
‫المعهد القومي لالورام‬
‫جامعة القاهرة‬
‫ددددددددددددددددددددددددددددد‬
‫مدرس طب االورام‬
‫المعهد القومي لالورام‬
‫جامعة القاهرة‬
‫المعهد القومي لألورام‬
‫جامعة القاهرة‬
‫‪2012‬‬
‫‪Page 2 of 12‬‬
‫)‪RCENCI Retrospective Protocol Template v1.0 (AZ‬‬
National Cancer Institute
Cairo University
Table of contents
Section
General Information
Abstract/synopsis
Introduction
Aim
Methods
Ethics
Finance
Publication Policy
References
Supplements
Page
4
This protocol template is created by Dr. Ahmed A. Zeeneldin (ENCI research center) for exclusive use of NCI postgraduate students. Use of this template other than this should get permission from and subsequently acknowledge
the author. You may contact the author via email (azeeneldin@gamil.com).
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National Cancer Institute
Cairo University
General Information:
1. The candidate name:
a. Qualifications
b. Address
c. Telephones
d. Emails
e. Other important information
2. The supervisors
a. Qualifications
b. Telephones
c. Emails
d. Other important information
3. The sponsor/Source of grant: The Egyptian National Cancer Institute, Cairo Univ, Egypt
a. Address: Fom El Khalig Square, Cairo
b. Telephones:
c. Email/website: http://www.nci.cu.edu.eg/
d. Other important information
4. The trial sites (clinical laboratory(ies) and other medical and/or technical department(s)
and/or institutions involved in the trial)
a. Address
b. Telephones
c. Emails
d. Other important information
(e.g. this study will recruit patients from the medical oncology departments of NCI,
CU as well as Mansura oncology center, MU. Routine blood tests, radiology and
pathology will be carried out in the respective departments in both centers. The
special testing for XXX (e.g. Ki67) will be done at NCI pathology dept only).
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National Cancer Institute
Cairo University
Abstract/synopsis (one page only)
Introduction:
Research question(s)
Aims
Methods (design, site, eligibility, sample size, endpoints, expected duration of the study)
Expected results
How your study will reflect on the NCI
Six Key words
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National Cancer Institute
Cairo University
I. Introduction
1.
Background disease Information (overview of incidence, etiology, presentation, diagnosis,
treatments……etc)
2.
Background investigational products/tests/technique Information (name, Description of
structure, mechanism of action or steps of a procedure, summarize the previous animal
studies and human phase I, II and III studies, Known benefits and hazards)
Research question
Expected results
How your study will reflect on the NCI
3.
4.
5.
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National Cancer Institute
Cairo University
II. Aim of the proposed study (this section should be reviewed with the
statistician):
1. Primary objective: Major scientific question expected to be answered by the study which
determines design and sample size.
2. Secondary Objectives: Additional questions to be addressed if possible.
3. End-points: Specify and define which primary end-point(s) (outcome measures) will be used
to answer this question (e.g. objective response, etc) and which secondary end-points (e.g.
toxic effects) will be studied. The primary endpoint is the one that will address the primary
objective of the trial and should be objectively measurable in all eligible patients.
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National Cancer Institute
Cairo University
III. Methods
1. Trial Design (this section should be written in collaboration with the statistician)
State retrospective, observational, single or multicenter, exact design (e.g. cohort, casecontrol)
2. Eligibility (inclusion and exclusion) and withdrawal criteria:
A. Inclusion criteria: (tumor type, histology and grade, extent/stage, measurable, prior
treatments, age, performance status, prior and concomitant diseases, minimum
required laboratory data, Informed consent)
B. Exclusion criteria (non-compliance, patients at high risk, prior treatments not allowed)
3. Assessment of efficacy and safety of the study treatment/procedure or test
A. Assessment of Efficacy
1. Specification of the efficacy parameters (e.g. RR, OS, PFS, rates of breast conservation).
2 .Methods for assessing of efficacy parameters (clinical e.g. RECIST, radiologic e.g. CT,
MRI, or lab tests)
3. Timing of assessments e.g. every 2 months
A. Assessment of Safety
1. Specification of safety parameters (toxicity, 30-day mortality, surgical complications).
2. The methods for assessing safety parameters (e.g. CTCAE, circumference of the arm)
3. Timing of assessments e.g. every visit
6. Quality Control and Quality Assurance
7. Statistics (This section should be written with the help of the statistician)
1. A description of the statistical methods to be employed
2. Timing of any planned interim analysis(ses).
3. The number of subjects planned to be enrolled (sample size). In multicentre trials, the
numbers of enrolled subjects projected for each trial site should be specified.
4. Reason for choice of sample size, including reflections on (or calculations of) the power
of the trial and clinical justification.
5. The level of significance to be used.
6. Procedure for accounting for missing data.
7. Procedures for reporting any deviation(s) from the original statistical plan (any
deviation(s) from the original statistical plan should be described and justified in
protocol and/or in the final report, as appropriate).
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National Cancer Institute
Cairo University
8. Data Handling and Record keeping: how data will be collected (e.g. abstracted from the
medical record onto paper case report forms) and how it will be complied (e.g. transcribed into
an Excel spreadsheet) and how the data will be analyzed (e.g. SPSS). Research records should
be kept for at least 3 years after the students gets the assigned degree. You shoud specifically
mention the following:
a.
b.
c.
d.
Source (location) of records to be reviewed:
Describe how the charts to be reviewed will be identified:
Describe who will identify charts to be reviewed
Describe how data (both paper and electronic) will be stored to safe-guard
confidentiality (e.g. in a locked cabinet, password protected computer):
e. Specify who will have access to harvested patient data:
f. Clarify long harvested patient data will be stored and how it will be destroyed
when no longer needed:
IV. Ethics:
The following issues have to be discussed in the protocol
1. Is informed consent (and may be assent for younger patients) needed or not and why?
2. Subject identification and protection of confidentiality
V. Financing
Financing: The name, address, telephone and fax number of the study “sponsor” must be
included in the protocol.
VI. Publication Policy:
This policy should explain when the trial results will be published, who will be the first author,
the co-authors and who will deserve acknowledgements, which restrictions apply on publication
of “side results” before the publications of the main results of the trial
VII. References
Use the Harvard (author and date) style
VIII. Supplements
This includes any additional relevant documents and should at least contain
1. Candidate’s curriculum vitae
2. Evidence of GCP training
3. Copy of the informed consent (assent) in Arabic if required
4. Data Collection Form (This form should list the data elements that will be collected from the
medical record. It should not contain any direct or indirect identifiers except for a unique
subject code.)
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National Cancer Institute
Cairo University
5. Coded Identifier List (This form should serve as the link between the unique subject code
and any identifiers you will need to conduct this chart review study [e.g., name , medical
record number, date of birth, address, telephone number, social security number])
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National Cancer Institute
Cairo University
APPENDIX A: DATA COLLECTION FORM
1.
2.
Unique Subject Code
List all elements to be collected during the chart review
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National Cancer Institute
Cairo University
APPENDIX B: CODED IDENTIFIER LIST
1.
Unique Subject Code
2.
List all identifiers to be collected or used in this study (e.g., name , medical record number, date of
birth, address, telephone number, social security number)
1.
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