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dbGaP phs001052 Multi-Dimensional ClinOmics for Precision Therapy - Eligibility

- 7/9/23 - 5 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: IG.elig
Principal Investigator: MeSH: Neoplasms,Sarcoma,Sarcoma, Ewing,Rhabdomyosarcoma,Wilms Tumor,Desmoplastic Small Round Cell Tumor,Carcinoma, Transitional Cell,Rhabdoid Tumor,Sarcoma, Synovial,Neuroblastoma,Neuroendocrine tumors https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001052 The Center for Cancer Research (CCR), of the intramural NCI undertook a multidimensional clinical genomics study of children and adolescent young adults with relapsed and refractory cancers who were enrolled on other therapeutic trials to determine the feasibility of a genome guided precision therapy protocol in these patients.

pht005466.v2.p1

1 itemgroup 2 items

pht005467.v2.p1

1 itemgroup 3 items

pht005468.v2.p1

1 itemgroup 3 items

pht005469.v2.p1

1 itemgroup 6 items

dbGaP phs001121 Integrated Genetic and Pharmacologic Interrogation of Rare Cancers - pht005711.v1.p1

- 6/19/23 - 5 forms, 1 itemgroup, 5 items, 1 language
Itemgroup: pht005711
Principal Investigator: William C. Hahn, MD, PhD, Dana-Farber Cancer Institute, Boston, MA, USA MeSH: Sarcoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001121 Due to the paucity of patient derived models in rare cancers, identification of therapeutic targets remains challenging. We developed a patient derived model, CLF-PED-015-T, from a patient with an undifferentiated sarcoma. From this model, we performed pooled RNAi and CRISPR-Cas9 negative selection screens and integrated that with a small molecule screen. Integration of these data identified CDK4 and XPO1 as potential therapeutic targets.

Eligibility

1 itemgroup 1 item

pht005708.v1.p1

1 itemgroup 2 items

pht005709.v1.p1

1 itemgroup 3 items

pht005710.v1.p1

1 itemgroup 4 items

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 NCT00876031 Soft Tissue Sarcoma - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 19 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00876031

Sarcoma NCT01247571 Pre-Study - GOG-0230: Fast Fact Sheet for Protocol 0230-D (Uterus) - 3174263v1.0 - GOG-0230: Fast Fact Sheet for Protocol 0230-D (Uterus)

- 9/20/21 - 1 form, 3 itemgroups, 91 items, 1 language
Itemgroups: Patient Information, Eligibility 1, Provide comments about this Fast Fact Sheet
GOG-0230: Fast Fact Sheet for Protocol 0230-D (Uterus) Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=97F2A353-AB36-7B12-E040-BB89AD432C3D

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Pathology Report

- 12/31/19 - 1 form, 6 itemgroups, 20 items, 1 language
Itemgroups: Administrative data, Primary, Histology Type, Histologic Grade, Specimens, Secondary
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Eligibility Stage I Adult Soft Tissue Sarcoma NCT00896961

- 4/24/16 - 1 form, 1 itemgroup, 19 items, 1 language
Itemgroup: Inclusion Criteria
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00896961

AEWS0331: Eligibility Worksheet DRKS00003782 NCT00020566 - AEWS0331: Eligibility Worksheet NCT00020566

- 7/3/15 - 1 form, 4 itemgroups, 13 items, 1 language
Itemgroups: Header, Patient demographics, Comments, CCRR MODULE
AEWS0331: Eligibility Worksheet NCT00020566 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BED15863-3519-3BB6-E034-0003BA12F5E7

Toxicity - Sarcoma - Adverse Event Form - 2286753v3.0 - Sarcoma - Adverse Event Form

- 1/9/15 - 1 form, 4 itemgroups, 21 items, 1 language
Itemgroups: CRF Header, Sarcoma: Form Administration, Sarcoma: Adverse Events, Comments
Sarcoma - Adverse Event Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DE953EB7-2CB8-2814-E034-0003BA12F5E7

Sarcoma NCT01533207 Follow-Up - Gynecologic Oncology Group Follow-Up Form (Form Q) - 2727848v1.0 - Gynecologic Oncology Group Follow-Up Form (Form Q)

- 1/9/15 - 1 form, 8 itemgroups, 32 items, 1 language
Itemgroups: HEADER MODULE, VITAL STATUS, NOTICE OF PROGRESSION, CA125 AND OTHER BIOMARKERS, NOTICE OF NEW PRIMARY, LATE ADVERSE EVENT, NON-PROTOCOL THERAPY, COMMENTS
Gynecologic Oncology Group Follow-Up Form (Form Q) Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=45808A16-A3A1-20DA-E044-0003BA3F9857

Sarcoma Pre-Study - GOG-0231D: Fast Fact Sheet for Protocol 0231-D (Uterus) - 3307969v1.0 - GOG-0231D: Fast Fact Sheet for Protocol 0231-D (Uterus)

- 1/9/15 - 1 form, 3 itemgroups, 73 items, 1 language
Itemgroups: Patient Information, Eligibility, Provide comments about this Fast Fact Sheet
GOG-0231D: Fast Fact Sheet for Protocol 0231-D (Uterus) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1F54BBE-5B83-73AD-E040-BB89AD4338D5

Follow-Up - Sarcoma - Functional Evaluation Form for Extremity Primary - 2290878v3.0 - Sarcoma - Functional Evaluation Form for Extremity Primary

- 1/9/15 - 1 form, 3 itemgroups, 22 items, 1 language
Itemgroups: CRF Header, Sarcoma: Form Administration, Sarcoma: Functional Evaluation
Sarcoma - Functional Evaluation Form for Extremity Primary Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E298AD03-E4A8-0934-E034-0003BA12F5E7

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