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Lighthouse- Roche Cancer Screening Collection Study
Scottsdale/Phoenix, Ariz.
The purpose of this study is to prospectively collect peripheral blood samples, general medical record information including demographics and medical history, as well as cancer screening outcomes and any cancer diagnosis confirmed during study participation. This information will be used to further develop and evaluate content, methodology, specimen processing and quality control for test application in cancer screening.
Closed for Enrollment
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A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease (DIVERSITYLTE)
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).
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A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis (SELECTIONLTE)
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).
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A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease
Scottsdale/Phoenix, Ariz.
This study will primarily evaluate the safety and efficacy of GS-5745 in adults with active Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by an Open Label Extension. Participants who complete the Blinded Treatment Period will be eligible to enroll in the optional Open Label Extension for an additional 44 weeks.
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A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Proof-of-Concept Study of GIC-1001 for the Management of Visceral Pain in Subjects Undergoing Sedation-Free, Full Colonoscopy
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the effectiveness and safety of GIC-1001, a new, orally-administered, colon analgesic drug, developed to manage visceral pain, as an alternative to sedation during a full colonoscopy.
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Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening BLUE-C
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The primary purpose of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
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Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis (SELECTION1)
Scottsdale/Phoenix, Ariz.
The primary purpose of this study is to evaluate the effectiveness and safety of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active ulcerative colitis (UC). Subjects who are biologic-naïve and biologic-experienced will be enrolled in Cohorts A and B, respectively. Treatment assignments will be randomized within each Cohort.
Participants who complete the study, or do not meet protocol response or remission criteria at Week 10, will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899).
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Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease
Scottsdale/Phoenix, Ariz.
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).
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Whole Exome Sequencing and Other Omics in Human Disease
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test new technology called Next Generation Sequencing (NGS) that may help identify possible useful genetic information for your clinical care. NGS is a procedure that looks at all of your genes (the genetic material you have inherited from your parents). In this study, we want to collect detailed family history of enrolled patients, when available through an electronic-based, pedigree tool, identify exomic variants in patients using whole exome sequencing, understand how patients use the results of the genomic sequencing, and create a data repository of clinical phenotypes of patients linked to their genomic variant.
We may conduct additional research on the information using various computational programs to better understand the genetic changes being reported. We also want to store samples and genetic information for future research using further tests to determine the clinical significance of genetic variants identified during the genomic testing process.
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