Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 8:01 AM
Study NCT ID:
NCT01004835
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2009-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Approximately 20 milliliters of blood will be dispensed as follows: 2 X 8.5 ml PAX DNA Tubes OR 2 mLs of Saliva may be collected from each patient in a provided container. Saliva will only be collected on those individuals who do not wish to undergo phlebotomy for blood collection.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2009-10-29', 'studyFirstSubmitQcDate': '2009-10-29', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene identification', 'timeFrame': 'end of study', 'description': "By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['migraine'], 'conditions': ['Migraine Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.', 'detailedDescription': "It is estimated that over one-third of the world's population suffers from persistent or recurrent pain. Migraine is highly heritable and the majority of juveniles who suffer from the disorder have a mother or father who also have the disease. The blood or saliva samples will go through DNA analysis and be sequenced for candidate genes or subjected to whole-genome sequencing. By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from the Migraine disease patient population at Scripps Clinic and around Southern California.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Family members (genetic duo or trio), consisting of an adolescent 10 to 18 years of age and at least one of their biologic parents willing to be participate in trial\n2. Adolescent and at least 1 biologic parent with Migraine diagnosis confirmed by Dr. Christy Jackson\n3. Is reliable, cooperative and willing to comply with all protocol-specified procedures and/or sub-study if consented\n4. Able to understand and grant informed consent\n\nExclusion Criteria:\n\n1. Patient has been previously enrolled in the MAP GeneBank at Scripps Clinic Registry\n2. Has a significant chronic medical condition (i.e.chronic meningitis or a secondary origin/cause of headache) which, in the investigator's option, may interfere with the patient's optimal participation in the study\n3. Treatment with any investigational agents or devices within 30 days preceding enrollment in the study\n4. Has undergone ECT within 90 days preceding enrollment in the study"}, 'identificationModule': {'nctId': 'NCT01004835', 'acronym': 'MAPS', 'briefTitle': 'The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Translational Science Institute'}, 'officialTitle': 'The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)', 'orgStudyIdInfo': {'id': 'HSC# 08-5099'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Migraine Disease', 'description': 'Patients 10 to 18 years of age with the diagnosis of Migraine disease and at least one of their biologic parents will be included in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scrippshealth', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Christy M Jackson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scrippshealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Translational Science Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Scripps Translational Science Institute', 'investigatorFullName': 'Eric Topol, MD', 'investigatorAffiliation': 'Scripps Translational Science Institute'}}}}