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

- 06-11-23 - 6 Formulieren, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: 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 Itemgroep 2 Data-elementen

pht010324.v2.p1

1 Itemgroep 4 Data-elementen

pht010325.v1.p1

1 Itemgroep 2 Data-elementen

pht010326.v2.p1

1 Itemgroep 5 Data-elementen

Eligibility

1 Itemgroep 9 Data-elementen

dbGaP phs001362 Linked Read Sequencing of Gastric Cancer Metastases - pht006342.v1.p1

- 26-02-23 - 4 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: pht006342
Principal Investigator: Hanlee Ji, MD, Stanford University School of Medicine, Stanford, CA, USA MeSH: Stomach Neoplasms,Krukenberg Tumor https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001362 In this study, linked read sequencing was performed on two ovarian metastases and matched normal tissue, from a patient with primary diffuse gastric cancer. Linked read sequencing is a DNA preparation technology whereby high molecular weight molecules of DNA are uniquely barcoded prior to fragmentation and sequencing, thus retaining information about genomic contiguity. This study performed an extended analysis of linked read sequencing data to resolve the complex structures of structural variants in the cancer genomes. Complex structural rearrangements were identified in the genomic region surrounding the known oncogene FGFR2, and the association between FGFR2 and gastric cancer metastasis was demonstrated in an organoid model.

pht006343.v1.p1

1 Itemgroep 3 Data-elementen

pht006344.v1.p1

1 Itemgroep 4 Data-elementen

pht006345.v1.p1

1 Itemgroep 6 Data-elementen

dbGaP phs000361 Genome-Wide Association Studies in Upper Gastrointestinal Cancers (Asian) - pht002221.v1.p1

- 12-10-22 - 4 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: pht002221
Principal Investigator: Philip R. Taylor, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA MeSH: Squamous Cell Carcinoma,Esophageal Cancer,Gastric Cancer https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000361 This project aims to conduct genome-wide association studies (GWAS) in two anatomically different upper gastrointestinal (UGI) cancer sites in two populations with distinctly different disease rates and genetic profiles. One population has very high rates for both esophageal squamous cell carcinomas (ESCCs) and gastric cancers (GCs) and is comprised of Asians (*the "Asian UGI GWAS"*), while the other population has low rates of ESCC and GC and includes non-Asians from the Americas, Europe, and Australia (*the "Non-Asian UGI GWAS"*). Study participants for the Asian UGI GWAS reported here (Illumina 660W Quad chip) were drawn from 2 studies, the Shanxi Upper Gastrointestinal Cancer Genetics Project (Shanxi) and the Linxian Nutrition Intervention Trial (NIT), a prospective cohort, and included a total of 1898 ESCCs, 1625 GCs, and 2100 controls. For the 2nd phase (8 TaqMan SNPs), additional subjects from Shanxi and NIT as well as subjects from the Shanghai Men's Health Study (SMHS), the Shanghai Women's Health Study (SWHS), and the Singapore Chinese Health Study (SCHS) were also included (217 ESCCs, 615 GCs, 1202 controls). Altogether 2115 ESCCs, 2240 GCs, and 3302 controls were genotyped in this study.

pht002222.v1.p1

1 Itemgroep 2 Data-elementen

pht002223.v1.p1

1 Itemgroep 5 Data-elementen

Eligibility

1 Itemgroep 3 Data-elementen

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Zytoreduktive Chirurgie / HIPEC Part 1

- 27-09-21 - 1 Formulier, 6 Itemgroepen, 75 Data-elementen, 1 Taal
Itemgroepen: Administrative Documentation, Physical Examination, Laboratory Data, Cytoreductive Surgery, Peritoneal Cancer Index, Type of surgery
Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Woche 12

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - PK Dosing Date Time

- 20-09-21 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: PK Dosing
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Zytoreduktive Chirurgie / HIPEC Part 2

- 02-09-21 - 1 Formulier, 7 Itemgroepen, 65 Data-elementen, 1 Taal
Itemgroepen: Administrative Documentation, Postoperative questions, Result of Surgery, Pathological tumor staging, Tumor staging, HIPEC, Administrative Documentation
Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Woche 12

Eligibility Early Gastric Cancer NCT01643811

- 01-12-19 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01643811

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - Study Conclusion, Treatment Confirmation, Pregnancy Information, Death

- 30-05-18 - 1 Formulier, 4 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Study Conclusion, Treatment Confirmation, Pregnancy Information, Death
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - Investigational Product Compliance-Lapatinib, Investigational Product Discontinuation

- 30-05-18 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Investigational Product Compliance-Lapatinib, Investigational Product Discontinuation
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - Blood Products and Blood Supportive Care Products, Paclitaxel Premedications

- 30-05-18 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Blood Products and Blood Supportive Care Products, Paclitaxel Premedications
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS

- 30-05-18 - 1 Formulier, 7 Itemgroepen, 43 Data-elementen, 1 Taal
Itemgroepen: NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, Relevant Concominant/Treatment Medications, Relevant Medical Conditions/Risk Factors, Relevant Diagnostic Results, Investigational Products, General Narrative Comments
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - Safety Assessment of Interstitial Pneumonitis, Continutation, Status, Concominant Medications

- 29-05-18 - 1 Formulier, 4 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Safety Assessment of Interstitial Pneumonitis, Continutation, Status, Concominant Medications
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

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