A Longitudinal, Case-Control Study to Collect Medical and Epidemiological Data and Blood Samples for Research Into the Causes of Multiple Sclerosis and Selected Demyelinating Diseases
Over 750 subjects will be interviewed and the interviewer will fill out a questionnaire (which includes questions about your lifestyle, environment, geographic [like: patient name, date of birth, address], medical history [like: medications, allergy information, diagnostic tests and previous labwork, neurological exams], and health status) and then review the subject and amp;apos;s medical record to verify clinical information. Once this questionnaire is complete, it will be entered into an electronic data capture system by the study coordinator and sent to a data management vendor chosen by the Sponsor. If a child is consented, the questionnaire will be completed by the parent/caregiver and then reviewed by the study coordinator.
Once the questionnaire process is complete, approximately 110 ml (about 22.3 teaspoons or 7.4 tablespoons) of blood from adults and up to 50mL of blood from children will be taken from the antecubital vein of the patient and #146;s arm. Children, age 17 and younger, must weigh at least 37lbs to participate in the study. Children weighing at least 37lbs will have no more than 50mL of blood collected. The blood sample will be taken one time during the initial study visit. No other blood samples will be taken without additional IRB approval, however, the Sponsor may choose to contact patients in the future and see if they are willing to come in again, reconsent, and possibly give another blood sample. This blood will be sent to a laboratory chosen by the Sponsor. The interview and blood sampling should take approximately 2 hours.
The subject will be assigned a unique barcode, which will be placed on all the material that is sent to the laboratory or data management vendor. Materials used in this study such as blood samples, medical records and questionnaire will be identified using this barcode, not by name. Samples of blood sent to the lab will not be linked to the patient in any way.
Each subject will complete a Confidential Contact Sheet (CCS) which will be forwarded to the Sponsor in order to facilitate periodic contact for longitudinal follow-up. The Sponsor will hold this link to the subject and #146;s identity in a separate protected, secure database. To facilitate the data query process, the Site will retain a copy of the CCS, which will allow the Site to maintain a temporary link connecting the barcode and the subject and #146;s name until all data queries are completed or until a maximum of six months has passed. The PI or study staff will be required to sign a CCS Disposal Form once the six-month period has expired to confirm that the temporary link has been severed.
This CCS will allow the Sponsor to have the subject and #146;s study doctor contact the subject every year or two to update contact information, ask new questions related to life style (for example, questions about dietary habits) or current health status, and perhaps ask for another blood sample similar to the one done during the initial interview. These contacts and blood sampling through the study doctor will continue over the life span of the subject. At any time, a subject can refuse additional interviews and blood sampling. The Sponsor will periodically send mail for the purpose of allowing the subject to provide updated contact information.
If a subject has experienced a demyelinating event characteristic of MS or one of the other demyelinating diseases specified, they will be asked to speak with certain types of family members and friends who may wish to participate in this study. The Sponsor is especially interested in enrolling family members (with or without a demyelinating disease). Friends with or without a demyelinating disease may also be eligible for this study. If they choose to contact the study doctor, the doctor will decide whether that person meets the requirements of the study.
In June 2007 Board 3 determined the study able to be expidited.
CRITERIA FOR INCLUSION OF SUBJECTS:
* Individuals with at least one CNS demyelinating event characteristic of MS, TM, ADEM, NMO or ON (a demyelinating event is defined as a symptom or constellation of symptoms referable to a disruption of the CNS white matter or myelin within gray matter). Characteristic syndromes include hemibody sensory or motor symptoms, mono-sensory symptoms, monoparesis, brainstem syndrome or cerebellar syndrome, lasting at least 24 hours and not acute in onset.
* Individuals at least 18 years old and able to give informed consent or individuals younger than 18 years old, with parental permission, and able to give assent.
* Individuals at least 18 years old willing and able to provide up to 110 ml blood via venipuncture or individuals 17 years old and younger (weighing at least 37 lbs.) willing and able to provide up to 50 ml blood via venipuncture.
5.2.3 CONTROL Inclusion criteria
1. Related and unrelated individuals who have not experienced any CNS demyelinating events characteristic of MS, TM, ADEM, NMO or ON, and have not been diagnosed with any demyelinating disease.
2. Individuals at least 18 years old and able to give informed consent or individuals younger than 18 years old, with parental permission, and able to give assent.
3. Individuals willing and able to provide up to 110 ml blood via venipuncture or individuals 17 years old and younger (weighing at least 37 lbs.) willing and able to provide up to 50 ml blood via venipuncture.