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dbGaP phs001003 Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets - pht010322.v2.p1

- 11/6/23 - 6 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: pht010322
Principal Investigator: Steven A. Rosenberg, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA MeSH: Colonic Neoplasms,Ovarian Neoplasms,Stomach Neoplasms,Cholangiocarcinoma,Pancreatic Neoplasms,Rectal Neoplasms,Esophageal Neoplasms,Colorectal Neoplasms,Endometrial Neoplasms,Paraneoplastic Syndromes, Ocular https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001003 Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer patients. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies. In this study, we performed whole exome and RNA-Seq analysis metastases to determine the nature and frequency of somatic mutations.

pht010323.v2.p1

1 Item-grupp 2 Dataelement

pht010324.v2.p1

1 Item-grupp 4 Dataelement

pht010325.v1.p1

1 Item-grupp 2 Dataelement

pht010326.v2.p1

1 Item-grupp 5 Dataelement

Eligibility

1 Item-grupp 9 Dataelement

Eligibility Cancer NCT00752570

- 11/10/17 - 1 Formulär, 2 Item-grupper, 19 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00752570

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - CRF Tracking/Review Forms

- 8/22/19 - 1 Formulär, 2 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Clinical Trial Regulatory Tracking Document
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Patient Assignment Sheet

- 8/21/19 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Patients, Assignment
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Serious Adverse Experiences (SAE)

- 8/20/19 - 1 Formulär, 6 Item-grupper, 31 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Serious Adverse Event, Serious Adverse Event. Laboratory test finding, Serious Adverse Event, Comment, Serious Adverse Event, Randomization, Serious Adverse Event, Investigator Signature
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Study Conclusion

- 8/20/19 - 1 Formulär, 3 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Clinical Trials, Conclusion, Investigator Signature
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Adverse Experiences (Non-serious)

- 8/20/19 - 1 Formulär, 2 Item-grupper, 15 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Non-Serious Adverse Event
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Concomitant Medication

- 8/19/19 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Concomitant Agent
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Form D

- 8/21/19 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Cessation of life
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Eligibility DRKS00003645 NCT00349076 Rectal Neoplasms - Eligibility

- 9/20/21 - 1 Formulär, 2 Item-grupper, 21 Dataelement, 2 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00349076

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Patient Log

- 8/21/19 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Patients, Exclusion
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Response Assessment

- 8/20/19 - 1 Formulär, 4 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Administrative documentation, TNM clinical staging, Rectal Carcinoma, Pathological staging, Rectal Carcinoma, Sphincter, Preservation technique
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

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