A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules

Date Added
November 5th, 2020
PRO Number
Pro00098515
Researcher
Nichole Tanner

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this research is to evaluate if including the investigational Nodify XL2 test results in the decision-making process when planning the management of lung nodules will reduce the number of unnecessary surgical and biopsy procedures. The general study procedures include obtaining blood samples for Nodify XL2 tests, collecting relevant medical information (including test results ordered by your doctor in the management of your lung nodule), and documenting your doctor's recommendations for the treatment of your lung nodule. Participation in this research study may last up to 18 months.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

Identification of Molecular and Genetic Variations Underlying Skin Diseases

Date Added
November 3rd, 2020
PRO Number
Pro00096209
Researcher
Colleen Cotton

List of Studies

Keywords
Cancer, Genetics, Infectious Diseases, Inflammation, Rare Diseases, Skin
Summary

Genetic changes to human skin contribute to a wide variety of conditions and diseases that affect over 20% of the population. However, the genes and molecules that are responsible for human skin development and disease are not fully understood, preventing the development of treatment options. This proposal seeks to better understand one disease in particular, linear morphea, a form of Sclerederma that can affect the skin, muscle, and bone. This study will recruit subjects to collect and use skin tissue for the purpose of identifying the genetic causes of linear morphea.

Institution
MUSC
Recruitment Contact
Alexandra Ritter
757-777-6673
ritteral@musc.edu

A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC

Date Added
November 3rd, 2020
PRO Number
Pro00104644
Researcher
Carol Sherman

List of Studies


Keywords
Cancer, Cancer/Lung
Summary

This study is for patients that have been diagnosed with Non-Squamous Non-Small-Cell Lung Carcinoma (NSCLC). The purpose of this study is to compare the two investigational treatments (cabozantinib alone to using cabozantinib plus the usual treatment nivolumab) to the current standard of care second line therapy. The study drugs involved are cabozanitib alone and cabozantinib plus nivolumab. Participants can expect to be on this study for up to 3 years.

Institution
MUSC
Recruitment Contact
Amanda Kelley, RN
864-725-7125
amanda.kelley@selfregional.org

Implementation and Effectiveness Trial of HN-STAR

Date Added
October 12th, 2020
PRO Number
Pro00104287
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients that have been diagnosed with head and neck cancer. The purpose of this study is to examine whether HN-STAR can help healthcare providers care for survivors of head and neck cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Date Added
September 25th, 2020
PRO Number
Pro00104024
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Acute Myelogenous Leukemia (AML). This study will compare standard chemotherapy using daunorubicin, cytarabine and gemtuzumab ozogamicin (GO) to chemotherapy using an experimental drug called CPX-351. CPX-351 is made up of daunorubicin and cytarabine. CPX-351 is made in a way that makes the drugs stay in the bone marrow longer and may be more effective. CPX-351 has been shown to be well-tolerated and effective against leukemia in adults and children. Participants can expect to receive treatment on this study for 6 months and followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
HCC Clinical Trials Office843-792-9321
hcc-clinical-trials@musc.edu

Prospective Non-Interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer Treated with Larotrectinib

Date Added
September 17th, 2020
PRO Number
Pro00090298
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This is an observational study, which means that only information is collected on treatment, examinations or diagnostic tests which are a part of the routine standard of care. The participant is being asked to volunteer because they have been diagnosed with locally advanced or metastatic TRK fusion cancer treated with larotrectinib. The purpose of this study is to learn more about the safety profile and the effectiveness of VITRAKVI® under routine practice conditions.
Participants will be followed for a minimum of 5 years from the time they agree to participate in the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer (COMPPARE)

Date Added
September 15th, 2020
PRO Number
Pro00102422
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

This study is for patients that have been diagnosed with prostate cancer. The purpose of this study is to directly compare photon (X-ray) therapy and proton therapy to determine which one has better disease control and fewer patient-reported and physician-reported side effects. Participants can expect to be in this study for a minimum of 3 years and up to 10 years, depending on funding.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

Date Added
September 2nd, 2020
PRO Number
Pro00102404
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Cancer, Pediatrics
Summary

This study is for patients that have been newly diagnosed with BRAF v600-Mutant High-Grade Glioma (HGG). The overall goal of this study is to see if using two drugs called dabrafenib and trametinib after radiation treatment will be better than treatments used in the past in helping to get rid of or shrink HGG. The treatment involves cancer fighting medicines plus radiation. The treatment on this study takes a little over 2 years. It is divided into 2 phases of therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase II Study of Metronomic and Targeted Anti-Angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma

Date Added
September 1st, 2020
PRO Number
Pro00091939
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Central Nervous System, Children's Health, Drug Studies, Pediatrics, Spinal Cord
Summary

This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trails@musc.edu

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Date Added
August 24th, 2020
PRO Number
Pro00096015
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Non-Small Cell Lung Cancer (NSCLC).The investigational drug used in this study is CLN-081.

This study has 3 parts; Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion:
-Phase 1 Dose Escalation: The main aim of this part of the study is to find a maximum tolerated dose for CLN-081. This will be done by slowly increasing the dose given to each participant or to small groups of participants until certain adverse effects are seen. All participants will be closely monitored by the study doctor and team. When the maximum tolerated dose has been found, it will be used in the subsequent parts of the study.
-Phase 1 Dose Expansion: In this part of the study more participants will receive the maximum tolerated dose to confirm the safety of this dose of the study medicine and to explore different dosing schedules, for example, taking the study medicine once a day versus twice a day.
-Phase 2a Dose Expansion: The main aim of this part of the study will be to see how well the study medicine works in reducing tumor size.

Participants can expect to be on this study for about 3 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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