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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
  7. 7. Medical Specialty
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dbGaP phs001657 Functional Genomic Landscape of Acute Myeloid Leukemia - phs001657.v1

- 5/12/22 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: AML_Subject,AML_Sample,AML_Sample_Attributes
The implementation of targeted therapies for acute myeloid leukemia has been challenged by complex mutational patterns within and across patients as well as a dearth of pharmacologic agents for most mutational events. Here, we report initial findings from the Beat AML program on a cohort of 672 tumor specimens collected from 562 patients. We assessed these specimens using whole exome sequencing, RNA-sequencing, and ex vivo drug sensitivity analyses. Our data reveal novel mutational events not previously detected in AML. We show association of drug response with mutational status, including instances of drug sensitivity that are specific to combinatorial mutational events. Integration with RNA-sequencing also revealed gene expression signatures, which predict a role of specific gene networks in drug response. Collectively, this report offers a dataset, accessible by the Beat AML data viewer, that can be leveraged to address clinical, genomic, transcriptomic, and functional inquiries into the biology of AML. NCT 01728402 https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001657.v1.p1

GSK Study ID 104864-201 Laboratory Tests - Laboratory Tests

- 4/1/22 - 1 form, 6 itemgroups, 84 items, 1 language
Itemgroups: Identification Numbers,Laboratory Tests-Hematology,Laboratory Tests-Blood Chemistry,Laboratory Tests-Urinalysis,Laboratory Tests-Bone Marrow Examination,Cytogenetics
Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

GSK Study ID 104864-201-Laboratory (next Course) - Laboratory Tests

- 3/31/22 - 1 form, 6 itemgroups, 83 items, 1 language
Itemgroups: Identification Numbers,Laboratory Tests-Hematology,Laboratory Tests-Blood Chemistry,Laboratory Tests-Urinalysis,Laboratory Tests-Bone Marrow Examination,Cytogenetics
Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Klinische Dokumentation Med. V - Follow Up AML - Klinische Dokumentation Med. V AML

- 1/31/22 - 1 form, 12 itemgroups, 94 items, 2 languages
Itemgroups: Patienten-Stammdaten,Diagnose: Akute myeloische Leukämie,Zuweiser,Vorausgegangene Therapie,Charakteristika bei Erstdiagnose,Rezidiv der AML,MRD-Verlauf,Nebendiagnosen,Biobank,Aktuelle Diagnostik,Aktueller Patientenstatus,Therapieverlauf
Dokumentation des Follow-Up für Patienten mit AML am Universitätsklinikum Heidelberg. Prof. Dr. med. Sascha Dietrich; Dr. med. Tim Sauer; Medizinischen Klinik V - Klinik für Hämatologie, Onkologie, Rheumatologie - Universitätsklinikum Heidelberg

Eligibility Acute Myeloid Leukemia NCT01010373

- 11/18/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01010373

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

On-Study - Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients - 2019404v4.0 - Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients

- 9/27/21 - 1 form, 4 itemgroups, 32 items, 1 language
Itemgroups: CRF Header,AML: Form Administration,AML: Disease Description,Comments
Acute Myeloid Leukemia (AML) - On-Study Form - Previously Untreated Patients Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8D071CA6-C045-F391-E040-BB89AD4376C0

Ersterhebung_Vor_Begleiterkrankungen CRF AML2003 AML - Ersterhebung_Vor_Begleiterkrankungen

- 9/27/21 - 1 form, 3 itemgroups, 17 items, 2 languages
Itemgroups: Allgemeine Angaben,Vor- und Begleiterkrankungen,Unterschrift
Prospektive, randomisierte, multizentrische Therapie optimierungsstudie - Studienprotokoll AML2003 http://clinicaltrials.gov/show/NCT00180102

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

Follow Up Status AML UKM

- 9/27/21 - 1 form, 6 itemgroups, 21 items, 2 languages
Itemgroups: Administrative Data,Diagnoses,Therapies/Procedures,Further details,Relapses,Further Comments
Routine documentation of University Hospital Muenster. Unit: Hematology and Internistic Oncology. Based on items of original form: FollowUp Tumornachsorge MS

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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