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STUDY14725
LUNGMAP: A Master Protocol To Evaluate Biomarker Driven Therapies And Immunotherapies In Previously Treated Non Small Cell Lung Cancer (Lung Map Screening Study)
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
Study Information
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STUDY20133
Pediatric Acute Leukemia (PedAL) Screening Trial Developing New Therapies for Relapsed Leukemias
To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available Phase I/II PedAL sub-trials. To maintain a longitudinal and comprehensive registry from relapse in children and young adults with recurrent and refractory leukemia.
Study Information
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STUDY21784
Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancer
The primary objective of this study is to determine the proportion of patients with stage IA2-III lung cancers who possess actionable oncogenic drivers. The screening approach will be considered feasible if, utilizing tumor or plasma assays, 35% of non-squamous non-small cell lung cancers are identified as having a actionable genomic alteration including ALK rearrangements, BRAFV600E mutations, EGFR sensitizing mutations, HER2 mutation, HER2 amplification, MET amplification, MET exon 14 mutation, RET rearrangements, NTRK rearrangement, KRAS G12C, or ROS1 rearrangements
Study Information
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STUDY23307
TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi Omic Biomarker Profiling Study of Patients with Non Small Cell Lung Cancer (NSCLC)
Primary Objectives:
To prospectively determine if a plasma-only ctDNA
methylation based minimum residual disease (MRD) assay
(i.e., xM) completed one month post-surgical resection +/-
adjuvant therapy can predict recurrence in patients with Stage
I-IIIa NSCLC at a minimum of two year follow up.
To prospectively determine if plasma-only ctDNA
methylation based MRD assay (i.e., xM) completed one month
post systemic therapy can predict recurrence or progression in
patients with Stage IIIb-IV NSCLC at a minimum of one year
follow up.
Endpoints: Recurrence-Free
Survival (RFS) or
Progression-Free
Survival (PFS) as
assessed by standard
radiographic imaging.
Secondary Objectives:
To determine the performance of a plasma-only ctDNA
methylation-based MRD assay through serial testing
To assess concordance between molecular biomarkers detected
in the tumor tissue and in plasma ctDNA using a broad-based
tissue and liquid NGS assays (i.e., xT and xF, respectively)
To characterize test performance by disease stage.
Endpoints: Sensitivity and
specificity; RFS or PFS
Percentage of variants
detected by both assays
Subgroup analysis of
sensitivity and
specificity by stage.
Exploratory Objectives:
To characterize the relationship between genomic results (xT,
xF, xM) and clinical outcomes based on collection of
longitudinal information from medical records
To determine if surgical biopsy introduces ctDNA into the
bloodstream
To study tumor heterogeneity by comparing molecular results
from biopsy and resection for patients with early-stage and
locally advanced NSCLC.
Endpoints: Clinical outcomes
based on xT, xF, xM
assay results
Compare ctDNA
detected before and
after biopsy
Variants detected from
biopsy specimen vs.
surgical resection
specimen from the
same patient
Study Information
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STUDY23809
Scale and Evaluate Smoking Cessation and COPD Screening E Visits to Rural Health Clinics
This study involves a stepped-wedge, cluster-randomized clinical trial (N=144) to examine the effectiveness of the COPD screening and smoking cessation e-visits vs. TAU for smoking cessation across 11 rural (Rural-Urban Commuting Area codes 4-10) primary care practices in South Carolina. In Aim 2, we will evaluate e-visit implementation outcomes across rural South Carolina primary care settings at patient, provider, and organizational levels. Outcomes will include those related to: e-visit feasibility (i.e., time to complete e-visit, time for provider to review e-visit, % completed e-visits, qualitative feedback), COPD (early diagnosis rates as a function of treatment condition, emergency department visits for respiratory infection), smoking cessation outcomes (self-reported quit attempts/quit duration and biochemically verified cessation via carbon monoxide), and cessation medication utilization.
Study Information