Diagnosis & Screening Trials

Every treatment that has ever made a difference in cancer care was once a part of a clinical trial. MUSC Hollings Cancer Center is committed to offering the best treatments available today while searching for even better ones for the future. Ask your doctor if a clinical trial is right for you.

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
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
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
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
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
STUDY24012
The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Primary Objective To evaluate the clinical performance of the FMBT-Lung (clinical validation), including sensitivity and specificity, in detecting lung cancer among subjects with positive and negative lung cancer outcomes during a 12-month follow-up period. 2.4 Secondary Objective To evaluate the clinical performance of the FMBT-Lung, including sensitivity and specificity, in detecting lung cancer among subjects with positive and negative lung cancer outcomes, during a 24-month follow-up period.

Study Information
STUDY24088
A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection

To determine the patient-level Correct Detection Rate (CDR) of copper Cu 64 PSMA I&T PET/CT in patients with Biochemical Recurrence (BCR) of PC. To determine the region-level Correct Localization Rate (CLR) of Copper Cu 64 PSMA I&T PET/CT in patients with BCR of PC.

Study Information
STUDY25659
A Multicenter Randomized Trial of EBUS-TBNA versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing: FROSTBITE-3

To evaluate the utility of adding transbronchial mediastinal cryobiopsy to endobranchial ultrasound- transbronchial needle aspiration (EBUS-TBNA) on its ability to improve the likelihood of acquiring tissue sufficient for next generation sequencing (NGS).

Study Information
STUDY26264
cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

The primary objective of this study is to train and validate the methylome profiling platform to discriminate cancer from non- cancer.

Study Information
STUDY22026
Health Education Approach to Lung Screening (HEALS) - Lung Cancer Screening and Biospecimen Collection Through a Patient Navigation Approach

Evaluate the impact of the patient navigation program on the proportion of patients who complete LCS, defined as undergoing an LDCT. Assess the feasibility and acceptability of the patient navigation program. Assess the impact of the patient navigation program on patient health related quality of life. Assess the impact of the patient navigation program on patient financial distress.

Study Information