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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 9/20/21 - 13 forms, 3 itemgroups, 11 items, 1 language
Itemgroups: Global Disease Course, Red Cell Transfusion, Platelet Cell Transfusion
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Physical Examination/Follow up

3 itemgroups 14 items

Administrative/Demographic Details

1 itemgroup 11 items

Medical History

3 itemgroups 9 items

Lab: Cytology/Cytogenetics/Cytochemistry

1 itemgroup 29 items

Lab: Immunophenotyping

1 itemgroup 17 items

Lab: Molecular Genetics

1 itemgroup 27 items

dbGaP phs001066 DNA and RNA Sequence of an Acute Lymphoblastic Leukemia - pht005280.v1.p1

- 6/23/23 - 4 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: pht005280
Principal Investigator: Richard K. Wilson, PhD, McDonnell Genome Institute, Washington University School of Medicine, St. Louis, MO, USA MeSH: Neoplasms,Leukemia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001066 We used massively parallel sequencing technology to profile the genomic DNA and RNA of tumor cells (leukemic bone marrow) and normal cells (skin biopsy) obtained from a single patient with Acute Lymphoblastic Leukemia (ALL), referred to throughout this study as 'ALL1'. Included in this study are samples obtained from a primary tumor, first relapse, second relapse and several intermediate timepoints. We identified somatic mutations present in each tumor by analysis of whole genome (WGS) and exome sequence data. Single nucleotide variants (SNVs) and small insertions and deletions were identified in both the exome and WGS data. Large copy number variations (CNVs) and structural variants (SVs) were identified in the WGS data. A custom capture reagent was designed to target most variants and used to generate deep validation sequence data. The expression status of all somatic variants was assessed by RNA-seq. The RNA-seq data was also used for gene expression analysis and gene fusion detection.

pht005281.v1.p1

1 itemgroup 3 items

pht005282.v1.p1

1 itemgroup 2 items

pht005283.v1.p1

1 itemgroup 5 items

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 11/18/21 - 9 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: Subject details
Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 itemgroups 84 items

On-Treatment 2

13 itemgroups 62 items

On-Treatment 4

12 itemgroups 62 items

On-Treatment 6

12 itemgroups 62 items

On-Treatment 7

13 itemgroups 67 items

On-Treatment 8

13 itemgroups 67 items

Follow-up AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML) - Follow-up AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

- 11/17/21 - 1 form, 5 itemgroups, 22 items, 1 language
Itemgroups: Follow-up, Concomitant Disease, Therapy, Allogenic Transplantation, Signature
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

On-Study - Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients - 2019420v3.0 - Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients

- 9/27/21 - 1 form, 4 itemgroups, 33 items, 1 language
Itemgroups: CRF Header, AML/MDS: Form Administration, AML/MDS: Disease Description, Comments
Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B24E8B9-F86C-508D-E044-0003BA3F9857

Leukemia NCT00085124 On-Study - CALGB: 10201On-Study Form - 2057573v3.0 - CALGB: 10201On-Study Form

- 9/27/21 - 1 form, 6 itemgroups, 39 items, 1 language
Itemgroups: CALGB Form, Patient Description, Organ Involvement, Current Symptoms, Lab data at Study Entry, CCRR MODULE
CALGB: 10201On-Study Form Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD838530-D422-2F4D-E034-0003BA12F5E7

Eligibility DRKS00005163 NCT01207388 B-ALL - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 14 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01207388

Eligibility DRKS00003796 NCT01209286 B-ALL - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 15 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01209286

Eligibility NCT01035502 Acute Myeloid Leukemia - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 24 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01035502

Swedish MDS registry - Myelodysplastic Syndrome - Registration

- 9/27/21 - 2 forms, 13 itemgroups, 76 items, 2 languages
Itemgroups: Registration form, Lead times, Diagnosis, Biobank, PREVIOUS DISEASE, Transfusions, Blood samples at diagnosis, Bone marrow at diagnosis, Cytogenetics at diagnosis, IPSS, Diagnosis reason, Treatment, Follow-Up
Source: Swedish National Quality Registry for Leukaemia http://www.cancercentrum.se/samverkan/cancerdiagnoser/blod-lymfom-myelom/

Myelodysplastic Syndrome - Follow-Up

10 itemgroups 83 items

Eligibility NCT01018069 Leukemia - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 19 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01018069

Eligibility NCT00989261 Acute Myeloid Leukemia - Eligibility AML NCT00989261

- 9/27/21 - 1 form, 2 itemgroups, 37 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations see http://clinicaltrials.gov/show/NCT00989261

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