Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:51 AM
Study NCT ID:
NCT03526666
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2018-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ascorbic Acid Levels in MDS, AML, and CMML Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-09', 'size': 484678, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-03T13:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Plasma with ascorbic acid redox analysis prep (additive: MPA solution, 10 % meta-phosphoric acid w/v containing 2 mM Na2EDTA)\n2. Plasma\n3. Buffy coat pellet'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral blood ascorbic acid levels', 'timeFrame': '1 year', 'description': 'The level of ascorbic acid'}], 'secondaryOutcomes': [{'measure': 'Evaluation of human endogenous retroviral sequences (HERVs) expression', 'timeFrame': '1 year'}, {'measure': 'Evaluation of 5-methylcitosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) levels', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin C', 'Ascorbic Acid', 'Epigenetics', '5-hydroxymethylcytosine', '5-methylcytosine'], 'conditions': ['Myelodysplastic Syndromes', 'Acute Myeloid Leukemia', 'Chronic Myelomonocytic Leukemia', 'MDS', 'AML', 'CMML']}, 'referencesModule': {'references': [{'pmid': '29102482', 'type': 'BACKGROUND', 'citation': 'Gillberg L, Orskov AD, Liu M, Harslof LBS, Jones PA, Gronbaek K. Vitamin C - A new player in regulation of the cancer epigenome. Semin Cancer Biol. 2018 Aug;51:59-67. doi: 10.1016/j.semcancer.2017.11.001. Epub 2017 Nov 2.'}, {'pmid': '27573823', 'type': 'BACKGROUND', 'citation': "Liu M, Ohtani H, Zhou W, Orskov AD, Charlet J, Zhang YW, Shen H, Baylin SB, Liang G, Gronbaek K, Jones PA. Vitamin C increases viral mimicry induced by 5-aza-2'-deoxycytidine. Proc Natl Acad Sci U S A. 2016 Sep 13;113(37):10238-44. doi: 10.1073/pnas.1612262113. Epub 2016 Aug 29."}]}, 'descriptionModule': {'briefSummary': 'This study is a non-interventional, specimen collection translational study to evaluate vitamin C levels in the peripheral blood of Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocytic Leukemia (CMML) patients.', 'detailedDescription': 'It has previously been established that hematological cancer patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) often exhibit severe vitamin C deficiency from a cohort of patients in Copenhagen. In this study, the investigators aim to determine if those results are conserved in another population/geographical location.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen in hematology/oncology clinics in Grand Rapids, MI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients actively receiving treatment for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n* Patients diagnosed with AML, MDS, or CMML and are treatment naïve.\n* Patients who are 18 years old or older.\n\nExclusion Criteria:\n\n* Patients deemed as too ill to participate as determined by the clinical investigator.\n* Non-English speaking patients\n* Patients unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03526666', 'briefTitle': 'Ascorbic Acid Levels in MDS, AML, and CMML Patients', 'organization': {'class': 'OTHER', 'fullName': 'Van Andel Research Institute'}, 'officialTitle': 'Collection of Peripheral Blood From Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia for Measuring Baseline Ascorbic Acid Levels and Future Epigenetic Cancer Research', 'orgStudyIdInfo': {'id': '17022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AML, MDS, and CMML patients', 'description': 'Patients with a diagnosis of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).', 'interventionNames': ['Other: Peripheral blood collection']}], 'interventions': [{'name': 'Peripheral blood collection', 'type': 'OTHER', 'description': 'Peripheral blood collection for the measurement of ascorbic acid levels and banking of plasma and buffy coat for future resrearch.', 'armGroupLabels': ['AML, MDS, and CMML patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cancer and Hematology Centers of Western Michigan', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49519', 'city': 'Wyoming', 'state': 'Michigan', 'country': 'United States', 'facility': 'Metro Health - University of Michigan Health', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}], 'overallOfficials': [{'name': 'Peter Jones, Ph.D., D.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Van Andel Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Van Andel Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cheif Scientific Officer', 'investigatorFullName': 'Peter Jones', 'investigatorAffiliation': 'Van Andel Research Institute'}}}}