Gknowmix Test Request


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Consent

I hereby give consent to services requested, guarantee payment and verify that all information is correct
The laboratory is allowed to release the diagnostic codes to my medical aid if necessary
My genetic material and clinical information may be included in in a database for research, related to the services requested, without revealing my identity
After completion of the genetic test my genetic material should be handled as follows:

Informed Consent Options

PARTICIPANT INFORMATION:

TITLE OF THE RESEARCH PROJECT:
The implementation of a comprehensive gene-based, pathology supported intervention program; for improved quality of life in patients diagnosed with multiple sclerosis (MS).

REFERENCE NUMBER:
N07/09/203

PRINCIPAL INVESTIGATOR:
Prof Susan J van Rensburg

ADDRESS:
Division of Chemical Pathology, Department of Pathology,
Tygerberg Hospital,
Cape Town, South Africa

CONTACT NUMBER:
+2721 938 4611

INFORMATION:
www.brainbiochem.com


Dear Participant

My name is Prof Susan van Rensburg. I would like to invite you to participate in a research project that aims to assess the role of genetic and environmental factors in multiple sclerosis (MS). Please take some time to read the information presented here, which will explain the details of this project and contact me if you require further explanation or clarification of any aspect of the study. Also, your participation is entirely voluntary and you are free to decline to participate.If you say no, this will not affect you negatively in any way whatsoever.You are also free to withdraw from the study at any point, even if you do agree to take part. This study has been approved by the Health Research Ethics Committee (HREC) at Stellenbosch University and will be conducted according to accepted and applicable National and International ethical guidelines and principles, including those of the international Declaration of Helsinki October 2008. MS is a condition in which the myelin, the fatty (lipid) covering around the nerve fibres in the brain, become damaged. This process, which is called demyelination, causes varying degrees of physical disability. MS is often presented as a progressively degenerative disease, inevitably resulting in paralysis and death. However, it has been shown over many years that disease outcome (disability) correlates with risk factors such as diet and smoking.The aim of the present study is to identify the risk factors for demyelination in specific individuals. Many of these risk factors have been known for many years, but some of them remain unknown, and it remains for us to identify them as well. It is also known that not everyone shares all the risk factors, but that they are specific for subsets of individuals, depending on genetic and environmental exposures to toxins. We plan to gather this information and identify the subsets of people by means of an online questionnaire as well as biochemistry and genetic tests.The benefit that you will derive from the study is that the risk factors impacting on your health as an individual may be identified, making it possible to give you information that may help to avoid disability progression. People who are not diagnosed with a demyelinating disease may also take part as control subjects. This will allow us to compare information obtained from people with and without symptoms of demyelination.

If you agree to take part, you would be able to choose between 3 options:

  1. Provide information about your family history and your own medical history, including your diet and your own thoughts on what may have caused demyelination in your case. If you agree to donate this information to our database, you will receive a FREE report which integrates your data with general information on lifestyle options that may improve your quality of life. The privacy and confidentiality of your data will be protected by giving you a code number when your data is transferred into the database, thereby removing your name from the data when it is applied for statistical analysis. In this way your data will be anonymised (confidential). Only the scientists and clinicians who generate and check your report will know to whom to send the Report. The average time of returning your Report should not be more than two weeks.
  2. In addition to the information provided above, you may choose to ask your doctor to participate in this project as well, as part of a doctor’s consultation. Your doctor will be requested to provide us with your body mass index, your blood pressure, a panel of blood test results and your Expanded Disability Status Scale (EDSS) score, where appropriate. The EDSS score is an objective measure of disability status, which we can correlate with the other information you provide to us in the online questionnaire. If you agree to provide us with this data, your doctor will receive a FREE report which integrates the results of your medical examination with your family and medical data, and you will receive personalised feedback on lifestyle options (based on published research data) that may improve your disease outcome. Your doctor will discuss the report with you and would be able to monitor your progress by repeating the blood tests and the EDSS scoring at future visits. The average time for you to obtain your results will depend on the release of the biochemistry results by the Pathology laboratory as well as the timing of your follow-up visit to the doctor.
  3. The third option is to request a genetic test (the Demyelinating Diseases Genescreen) in addition to Option 2 described above. You may read information about the test on the Gknowmix website at www.gknowmix.com. This test costs R1760 (about $190). Your doctor will receive a Report of the results of the genetic test, together with a simplified Report for you, which incorporates the results of the genetic test with your family and personal medical history, your blood test results and your EDSS if available. If you choose this option you will be required to give additional consent for genetic testing and the genetic test results will form part of the medical information included in the confidential research database www.gknowmix.org

A. If you are willing to participate in this study, please give consent online by clicking one of the boxes below. You will receive a code number that will be sent to your email address to verify that the person giving the consent is the same person providing the data. You will also receive the link to access the online questionnaire.

Please choose one of the following options:

1. Yes, I would like to receive access to the online questionnaire. I agree that the data I provide may be entered into the BrainBiochem database, under my code number. I understand that the Research Team will be able to link my data with my name in order to send my FREE report to me, but the data in the database will be stored under my code number only for data analysis.
2. Yes, I would like to receive access to the online questionnaire. I would also like to provide the contact details of my medical health professional who would be able to request blood tests and do a medical examination. I understand that the Research Team will be able to link my data with my name in order to send a FREE Report to my doctor who will discuss it with me, but the data in the database will be stored under my code number only for data analysis.
3. Yes, I would like to request the genetic test (the Demyelinating Diseases Genescreen) in addition to Option 2. I would like to provide the contact details of my medical health professional who would be able to do a medical examination, request blood tests and obtain a blood sample or a saliva sample for collection by the laboratory for DNA extraction and genetic testing. I understand that the Research Team will be able to link my data with my name in order to send a Report to my doctor who will discuss it with me, but the data in the database will be stored under my code number only for data analysis.

B. By selecting the checkbox below, I agree to take part in a research study entitled "The implementation of a comprehensive gene-based, pathology supported intervention program for improved quality of life in patients diagnosed with multiple sclerosis (MS)."

Declaration by participant

I declare that:

I have read the information provided about the project and it is written in a language with which I am fluent and comfortable. I understand that I can ask questions any time and all my current questions have been adequately answered. I understand that taking part in this study is voluntary and I have not been pressurised to take part. I may choose to leave the study at any time and will not be penalised or prejudiced in any way. I may be asked to leave the study before it has finished, if the researcher feels it is in my best interests, or if I do not follow the study plan, as agreed to.

I agree (Section B Declaration as stated here)

Many thanks for participating in this study and for providing informed consent for this on-line.

Yours sincerely
Susan J van Rensburg
Principal Investigator


Medical Aid Information

Medical aid
Plan Option
Member Number
Reference / Authorization No
ICD-10 Code
Medical Aid Motivation
Include Medical Aid Motivation in Quote

Personal Medical Conditions

Age of OnsetMedication
Alzheimers Disease
Anaemia / iron deficiency
Arthritis / Osteoarthritis
Cardiomyopathy
Cardiovascular Disease
Chronic Fatigue
Chronic Inflammation
Chronic Periodontitis
Coronary Heart Disease
Deep Vein Thrombosis
Dyslipidaemia
Familial Hypercholesterolaemia
Gum Inflammation
Haemochromotosis / High Iron
High Cholesterol
Hypertension / High Blood Pressure
Hypothyroidism
Insulin Resistance
Ischaemic cerebrovascular disease
Metabolic Syndrome
Multiple Sclerosis
Non-alcoholic fatty liver disease
Obesity / Overweight
Osteoporosis
Peripheral Vascular Disease
Polycystic ovary syndrome
Porphyria / Variegate porphyria
Pulmonary Embolus
Recurrent Pregnancy Loss / Infertility
Restless legs syndrome
Schizophrenia
Sinusitis
Sleep Apnea
Stress / Anxiety / Depression
Stroke
Thrombosis
Transient Ischaemic Attack
Type II Diabetes / High blood sugar
Vascular Dementia
Cancer Type
Cancer type Other
Cancer subtype / mutation (e.g. BRCA1,2)
Cancer recurrence - age(s)
Cancer metastasis - organ(s) affected
Other Condition 1
Other Condition 2
Other Condition 3
Other Condition 4
Other Condition 5

Family Medical Conditions

Age of OnsetFamily Relation
No family history due to adoption
Alzheimers Disease
Anaemia / iron deficiency
Arthritis / Osteoarthritis
Cardiomyopathy
Cardiovascular Disease
Chronic Fatigue
Chronic Inflammation
Chronic Periodontitis
Coronary Heart Disease Disease (e.g. Angina, myocardial infarction)
Deep Vein Thrombosis
Dyslipidaemia
Familial Hypercholesterolaemia
Haemochromotosis / High Iron
High Cholesterol
Hypertension / High Blood Pressure
Hypothyroidism
Insulin Resistance
Ischaemic cerebrovascular disease
Metabolic Syndrome
Multiple Sclerosis
Non-alcoholic fatty liver disease
Obesity / Overweight
Osteoporosis
Peripheral Vascular Disease
Polycystic ovary syndrome
Porphyria / Variegate porphyria
Pulmonary Embolus
Recurrent Pregnancy Loss / Infertility
Restless legs syndrome
Schizophrenia
Sleep Apnea
Stress / Anxiety / Depression
Stroke
Thrombosis
Transient Ischaemic Attack
Type II Diabetes / High blood sugar
Vascular Dementia
Cancer Type
Cancer Type Other
Other family medical conditions 1
Other family medical conditions 2
Other family medical conditions 3
Other family medical conditions 4
Other family medical conditions 5

Medical Data

Please use a decimal point (.) not a comma when capturing medical data

Please use a decimal point (.) not a comma when capturing medical data

Total cholesterol (TC) mmol/L
LDL-cholesterol (LDLC) mmol/L
HDL-cholesterol (HDL) mmol/L
Triglycerides, fasting mmol/L
TC:HDL Ratio
Lipoprotein (a) (Lp (a)) nmol/l
Fibrinogen g/L
D-dimer mg/L
Platelets x 10^9/L
Homocysteine (Hcy) umol/L
Serum folate nmol/L (µg/L x 2.31 to convert to nmol/L)
Vitamin B12 ng/L or pmol/L
C-reactive protein (CRP) mg/L
High-sensitivity C-reactive protein (CRP) mg/L
Glucose, fasting mmol/L
Glycosylated hemoglobin (HbA1c) %
Serum ferritin ng/mL
Serum iron umol/L
Transferrin g/L (divide µmol/L by 12.6 to convert to g/L)
Transferrin saturation %
Haemoglobin g/dL
Red cell count x 10^12/L
Erythrocyte sedimentation rate mm/hr
Thyroid stimulating hormone (TSH) mIU/l
Free T3 pmol/L
Free T4 pmol/L
25-OH Vitamin D ng/ml (divide by 2.5 to convert nmol/L to ng/ml)
Other pathology test results
Blood pressure – Systolic mmHg
Blood pressure – Diastolic mmHg

Lifestyle & Nutrition Assessment

Weight kg
Height m
Body mass index (BMI) kg/m^2
Waist circumference cm
Hip circumference cm
Waist to Hip Ratio Waist/Hip
Contraceptive pill
Hormone replacement therapy
Pregnant
Number of weekly Physical Activities > 30 Minutes
DAYTIME ACTIVITY
SMOKER
Alcohol Intake

Nutrition Assessment

Dietary Questionnaire

Hamburgers, Pizza
Red Meat e.g. Beef, Lamb, Mutton
Fried Chicken/ Cooked Chicken with skin
Hot Dogs / Sausages
Salad dressing (excluding 'Lite' versions)
Butter and Margarine (excluding pro-active versions)
Fried eggs (excludes cooking, boiling and baking)
Full cream milk and dairy products (fresh, sour or powdered)
Fried hot potato chips, potato crisps, corn chips, popcorn
Biscuits, cake, cookies, pastries
All Legumes (beans, peas, lentils)
Potatoes with skin
At least 5 portions fruits and vegetables (per day)
Whole grain breads. cereals (low GI wheat, oats)
Broccoli, cauliflower, mushrooms
Turnips, artichokes, asparagus
Avocado, spinach
Oranges, grapefruits (pure fruit versions)
Organ meats (e.g. liver, kidney, giblets)
Fizzy drinks, tea/coffee with sugar
Food Intolerance or Allergy
Food supplements taken daily
Food supplements taken occasionally
Food preferences such as vegetarian or vegan
Iron / vitamin B12 injections
Blood Donor
Prolonged exposure to environmental toxins (e.g. agricultural pesticides, occupational solvents)

Medication side effects/failure?

Cholesterol-lowering statins (e.g. muscle pains)
Anti-depressants (e.g. weight gain)
Immunomodulating drugs (e.g. depression) ?
Anti-retrovirals (e.g. weight gain, dyslipidaemia)
Other, (e.g. tamoxifen resistance)

Genetic Testing

Patient Deceased
HLA-DRB1 - Allele 1501
APOE4 T > C
APOE2 C > T
MTHFR 677 C > T
MTHFR 1298 A > C
FV Leiden G > A
F2 20210 G > A
PAI-1 / SERPINE1 4G / 5G
HFE C282Y G > A
HFE H36D C > G
TMPRSS6 C > T
FTO T > A
GNB3 - 825 C > T, splicing
ADRB2 C > G
FABP2 G > A
PPAR gamma C > G
Interleukin-6 - -174 G > C
TNF alpha G > A
GSTT1 NULL
GSTM1 NULL
MnSOD T > C
COMT G > A
CYP2D6 - 2549 del A, allele 3
CYP2D6*4 G > A
Research Number