Current Clinical Trials

Cardiac

• This is an international, multicenter, parallel-group, randomized, double-blind, placebo-controlled trial in patients who have been stabilized during hospitalization for acute heart failure, evaluating the effect of in-hospital initiation of dapagliflozin versus placebo on the clinical outcome of cardiovascular death or worsening heart failure.
  • Study ID: DAPA ACT HF-TIMI 68
  • Principal Investigator: Puvanalingam Ayyadurai, MD, FACC
• This is a Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
  Primary Objective: To evaluate the efficacy of oral PCSK9 inhibitors (Enlicitide) compared with placebo in increasing the time to the first event of CHD death-based MACE plus.
  • Study ID: CORALreef MK-0616-015  
  • Principal Investigator: Puvanalingam Ayyadurai, MD, FACC

Gynecology

• Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
  • STUDY ID: ECHO
  • Principal Investigator: Collette Lessard, MD

Oncology

• Blood
  • A Post-authorization Safety Study to Evaluate the Incidence of and Risk Factors for Severe and Fatal Infusion-related Reactions in Participants Treated with Daratumumab (Intravenous or Subcutaneous)
    • STUDY ID: HALO
    • Principle Investigator: Grant Seeger, MD
• Breast
  • TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer.
    • Study ID: CCTG MA.39
    • Principal Investigator: Grant Seeger, MD
  • Evaluation of Lasofoxifene Combine with Abemaciclib Compared with Fulvestrant Combined with Abemaciclib in Locally Advanced or Metatstatic ER+/HR2- Breast Cancer with an ESR1 Mutation
    • STUDY ID: ELAINE 3
    • Principal Investigator: Grant Seeger, MD
  • DEBRA: De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer
    • Study ID: DEBRA
    • Principal Investigator: Grant Seeger, MD
• Lung
  • This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.
    • Study ID: PACIFIC-4/RTOG-3515
    • Principal Investigator: Grant Seeger, MD
  • MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK).
    • Study ID: SWOG S1827
    • Principal Investigator: Grant Seeger, MD
  • Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer
    • Study ID: NRG LU008
    • Principal Investigator: Grant Seeger, MD
  • A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants with Non-Small Cell Lung Cancer
    • STUDY ID: V940-002
    • Principal Investigator: Grant Seeger, MD
• Prostate
  • This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer. Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy.
    • Study ID: Alliance A222001
    • Principal Investigator: Grant Seeger, MD
  • Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE).
    • Study ID: NRG GU010
    • Principal Investigator: Grant Seeger, MD
  • Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)
    • Study ID: NRG GU009
    • Principal Investigator: Grant Seeger, MD
  • A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with Metastatic Castrate-resistant Prostate Cancer (MCrPC), Stratified by Aggressive Variant Signature.
    
    Primary Objectives: 1. To compare radiographic progression free survival (rPFS) between the two treatment arms in the subset Aggressive Variant Prostate Cancer – Molecular-Pathologic Signature (AVPC-MS)-positive participants. 2. If the AVPC-MS positive test is statistically significant, test in AVPC-MS negative participants whether the combination of carboplatin and cabazitaxel improves rPFS.
    • Study ID: SWOG S2312
    • Principal Investigator: Grant Seeger, MD
  • The Phase III ‘HIGH FIVE TRIAL’ Five Fraction Radiation for High-Risk Prostate Cancer.
    
    Primary Objective: To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (SBRT) to those randomized to moderate hypofractionation and conventional fractionation.
    • Study ID: NRG-GU013
    • Principal Investigator: Grant Seeger, MD

Biorepository

• The PROACT LUNG Study: A Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
• Study ID: PROACT
• Principle Investigator: Grant Seeger, MD

You can learn more about clinical trials by visiting clinicaltrials.gov, which is a database of privately and publicly funded clinical studies conducted around the world. 

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Altru Health System, Research
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Email: adagoberg@altru.org