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dbGaP phs000673 University of Michigan Clinical Sequencing Exploratory Research (CSER) - Eligibility

- 1/25/23 - 5 forms, 1 itemgroup, 16 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Arul Chinnaiyan, MD PhD, Michigan Center for Translational Pathology, University of Michigan, MI, USA MeSH: Neoplasms,Breast Neoplasms,Sarcoma,Prostatic Neoplasms,Aromatase Inhibitors,Hematologic Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000673 Overview. The personalization of therapy for cancer will require molecular characterization of unique and shared genetic aberrations. In particular, patients who have a sarcoma or other rare cancers and are candidates for clinical trials could potentially benefit by identifying eligibility for "targeted" drugs based on the "actionable" genes in their specific tumor. Growing technological advances in genomic sequencing has now made it possible to consider the use of sequence data in a clinical setting. For instance, comprehensive testing that includes whole exome and transcriptome sequencing may identify biomarkers for predictive or prognostic purposes and thereby inform treatment choices and prevention strategies. Thus, the translation of high throughput next generation sequencing would support a "personalized" strategy for cancer. However, the translation of clinical sequencing bears unique challenges including identifying patients who could benefit, developing informed consent and human subjects protections, outlining measurable outcomes, interpreting what results should be reported and validated, and how results should be reported. In addition, we know very little about how patients and clinicians will respond to the potentially confusing and overwhelming amount of information generated by genomic sequencing, and we lack model processes for clinically evaluating and presenting these data. For the promise of our innovative biotechnologies to be realized, "translational genomics" research that evaluates genomic applications within real-world clinical settings will be required. This proposal brings together expertise at the University of Michigan including clinical oncology, cancer genetics, genomic science/bioinformatics, clinical pathology, social and behavioral sciences, and bioethics in order to implement this clinical cancer sequencing project. Three integrated Projects have the following themes: Project 1) "Clinical Genomic Study" will identify patients with a rare cancer (i.e., 15 out of 100,000 individuals per year) who are eligible for clinical trials, consent them to the study, obtain biospecimens (tumor tissue, germline tissue), store clinical data, and assemble a multi-disciplinary Sequencing Tumor Board to deliberate on return of actionable or incidental genomic results; Project 2) "Sequencing & Analysis" will process biospecimens and perform comprehensive sequencing and analysis of tumors to identify point mutations, copy number changes, rearrangements/gene fusions, and aberrant gene expression; Project 3) "Ethics & Psychosocial Analysis" will observe the expert review process for evaluating sequence results and will examine the clinician and patient response to the informed consent process, delivery of genomic sequence results, and use of genomic results.

pht003661.v4.p1

1 itemgroup 5 items

pht003662.v4.p1

1 itemgroup 4 items

pht003663.v4.p1

1 itemgroup 9 items

pht003660.v4.p1

1 itemgroup 5 items

Eligibility NCT00405743 Hematologic Malignancies - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 25 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00405743

Eligibility Acute Leukaemia NCT01521611

- 9/17/21 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Targeted Radiotherapy in HSCT for Poor Risk Haematological Malignancy; ODM derived from: https://clinicaltrials.gov/show/NCT01521611

Eligibility Lymphoma NCT00113646

- 4/13/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT00113646

Eligibility Hematological Malignancies NCT01816230

- 5/28/20 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM; ODM derived from: https://clinicaltrials.gov/show/NCT01816230

Eligibility Lymphoma NCT00621244

- 3/7/17 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT00621244

Manual for tumor documentation in MEDICO Organ specific tumor documentation DCP03 - Manual for tumor documentation in MEDICO- Appendix 3: Organ specific tumor documentation DCP03-Hematologic oncology

- 2/6/17 - 1 form, 3 itemgroups, 40 items, 1 language
Itemgroups: Tab 4 Histology, Tab 5 Ann Arbor, Tab 8 Other classifications
"Zur Dokumentation der Tumorerkrankungen wurde in Medico eine dem ADT/ GEKID konforme Tumordokumentation eingerichtet. Sukzessive wurde sie mit zusätzlichen Merkmalen ergänzt, damit alle notwendigen Informationen, die auch zur vollständigen Dokumentation der Tumorboardbeschlüsse und zur Bedienung diverser Anfragen erforderlich sind, in Medico abrufbar sind." Dieses Handbuch bezieht sich auf die Tumordokumentation im "Basisbogen" der Medico-Tumordokumentation und auf die Dokumentation solider Tumore. Spezifische Dokumentationsmerkmale für systemische Erkrankungen und multiple Hauttumore werden folgen. Für die Anlage des Basisbogens in Medico und Anmeldung zum Tumorboard sowie für die Dokumentation des Tumorboards inklusive des zugehörigen Beschlusses wurde jeweils eine eigene Anleitung erstellt. Diese stehen allen Mitarbeiterinnen und Mitarbeitern im QM-Handbuch des UK Essen über das Dokumentenmanagementsystem roXtra zur Verfügung. https://roxtra.uk-es-sen.de/Roxtra/preview/pdf/Anlegen+des+Basisbogens+und+Anmeldung+zur+Tumorkonferenz.pdf?Type=PDF&FileID=33846 https://roxtra.uk-essen.de/Roxtra/preview/pdf/Dokumentation+der+Tumorkonferenz.pdf?Type=PDF&FileID=33851

Eligibility Leukemia NCT00027560

- 7/24/16 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00027560

Eligibility Advanced Malignancy NCT01723020

- 4/29/16 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01723020

Eligibility Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors NCT00185679

- 2/5/16 - 1 form, 4 itemgroups, 53 items, 1 language
Itemgroups: Inclusion Criteria Recipient, Exclusion Criteria Recipient, Inclusion Criteria Donor, Exclusion Criteria Donor
Haploid Allogeneic Transplant Using the CliniMACS System; ODM derived from: https://clinicaltrials.gov/show/NCT00185679

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