Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-03-05 @ 3:01 PM
Study NCT ID:
NCT01850459
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2013-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracellular Signal-Related Kinase Biomarker Development in Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'For the ERK activation assay, about 5 mL of whole blood is layered onto 3 mL Histopaque in a 15 mL centrifuge tube, and centrifuged. The lymphocyte-containing cell layer is removed and transferred for washing. After a second wash, cells are resuspended and rested. They are then stimulated by addition of phorbol myristate acetate and sample aliquots are removed at short intervals, fixed and permeabilized. Fixed, permeabilized cells are stained by addition of Alexafluor488-labeled monoclonal antibody to phospho-ERK in the dark for 30 min. Washed, resuspended cells are analyzed in a Coulter flow cytometer.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-07', 'lastUpdatePostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ERK activation', 'timeFrame': 'Up to three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorders']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to establish a way to help the development of targeted treatments in autism spectrum disorders. This may also help in early diagnosis of autism and may possibly predict severity. The study will compare subject's ERK (extracellular signal-related kinase) signaling to age- and gender-matched neurotypical controls and Intelligence quotient (IQ)-matched developmental disabilities.", 'detailedDescription': 'Autism Spectrum Disorder Subject Criteria:\n\nInclusion Criteria:\n\n* Diagnosis of autism spectrum disorder, based upon a clinical interview utilizing the Diagnostic and Statistical Manual-V (DSM-V)\n* Age 3-25 years\n* Stable dosing of psychotropic drugs for greater than or equal to 5 half-lives\n\nExclusion Criteria:\n\n* Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on Diagnostic and Statistical Manual-V criteria\n* Use of lithium, riluzole or other known modulators of ERK activation\n\nAge-Matched Neurotypical Control Subjects:\n\n* Age matched to the age of an Autistic Disorder Subject\n* History of normal development\n\nIQ-Matched Control Subjects:\n\n* Those subjects who are included in the study based on having an IQ and age that matches the IQ and age of an Autistic Disorder Subject who has an IQ less than 70\n* All IQ-Matched Control Subjects will then also have an IQ less than 70'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The subjects with autism will be recruited through the clinic population at Cincinnati Children's Hospital Medical Center. Recruitment of subjects will be conducted by notifying via, IRB approved electronic and paper ads, individuals with autistic disorder, their families, treating clinicians and agencies throughout the referral base of CCHMC and those within our existing clinical services, residential facilities, schools and group homes for the developmentally disabled.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (ASD subjects):\n\n* Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V\n* Age 3-25 years\n* Stable dosing of psychotropic drugs for 5 half-lives or greater\n\nExclusion Criteria (ASD subjects):\n\n* Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on DSM-V criteria\n* Use of lithium, riluzole or other known modulators of ERK activation\n\nIQ-Matched Control Subjects: Those subjects who are included in the study based on having an IQ and age that matches the IQ and age of an Autistic Disorder Subject who has an IQ less than 70. All IQ-Matched Control Subjects will then also have an IQ less than 70. IQ-Matched Control Subjects participate in a Screen/Baseline visit only.\n\nAge-Matched Neurotypical Control Subjects: Those subjects who are included in the study based on having an age matched to the age of an Autistic Disorder Subject and a history of normal development. Age-Matched Neurotypical Subjects participate in a Screen/Baseline visit only.\n\nShipped Biomarker Control Group Subjects: For these shipping control samples, blood samples will also be drawn from adult parent/guardians of participating subjects.'}, 'identificationModule': {'nctId': 'NCT01850459', 'acronym': 'ERK', 'briefTitle': 'Extracellular Signal-Related Kinase Biomarker Development in Autism', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Extracellular Signal-Related Kinase Biomarker Development in Autism', 'orgStudyIdInfo': {'id': 'CIN001- ERK in Autism'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autism Spectrum Disorder group', 'description': 'Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V'}, {'label': 'IQ-Matched Control Subjects'}, {'label': 'Age-Matched Neurotypical Controls'}, {'label': 'Shipped Biomarker Control Group Subjects', 'description': 'These subjects provide a blood sample only that serves as a shipping control that is shipped along with all blood samples from Autistic Disorder Subjects, IQ-Matched Control Subjects or Age-Matched Neurotypical Control Subjects. For these shipping control samples, blood samples will also be drawn from the subjects.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Craig A. Erickson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}