BLINDED REFERENCE SET FOR MULTICANCER EARLY DETECTION BLOOD TESTS

Date Added
January 24th, 2023
PRO Number
Pro00125723
Researcher
Brian Hess

List of Studies


Keywords
Cancer
Summary

This study is for patients with cancer and is being done to see if blood samples from patients with and without certain types of cancer help researchers develop a future blood test for use in detecting cancer early.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

Mental Fatigue and Self-Care in Informal Oncology Caregivers: A Descriptive Mixed Methods Study

Date Added
October 7th, 2022
PRO Number
Pro00122174
Researcher
Megan Wayne

List of Studies

Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Mental Health, Non-interventional
Summary

This study is for anyone 18 years or older who provides unpaid care for a loved one living with cancer outside of the hospital setting. The purpose of this study is to help future caregivers and patients by learning how mental fatigue affects caregivers of persons living with cancer and determine if mental fatigue, participating in self-care activities, and general caregiver quality of life are related. Informal caregivers will be invited to complete a confidential, online survey that takes between 25 and 35 minutes to finish. Caregivers who complete the survey may be contacted and asked to participate in a 45-60 minute follow up interview either online or via phone if they are interested. The results of this study will help guide future research to identify ways healthcare professionals can help caregivers handle the stresses of caregiving and provide the best care possible to their loved ones at home.

Institution
MUSC
Recruitment Contact
Megan Wayne
8433070366
wayneme@musc.edu

A RANDOMIZED TRIAL ADDRESSING CANCER-RELATED FINANCIAL HARDSHIP THROUGH DELIVERY OF A PROACTIVE FINANCIAL NAVIGATION INTERVENTION (CREDIT)

Date Added
September 20th, 2022
PRO Number
Pro00123329
Researcher
Andrea Abbott

List of Studies


Keywords
Cancer
Summary

This study is for patients with cancer and the purpose of the study is to find out if receipt of online financial education about cancer care costs and financial concerns during cancer treatment plus financial navigation is more effective than the receipt of online financial education alone at helping households avoid financial problems after a cancer diagnosis.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

Neuroendocrine Tumors Patient Reported Outcomes (NET-PRO)

Date Added
August 23rd, 2022
PRO Number
Pro00120896
Researcher
William Lancaster

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Lung
Summary

The purpose of this research study is to gain patient feedback around their Neuroendocrine tumor (NET) diagnosis, including symptoms and quality of life with different NET treatments, factors that influence the order of treatments given, and how the order of NET treatments affect patient's quality of life, symptoms and survival. The main eligibility criteria for this study are being 18 or older and receiving the diagnosis of a neuroendocrine tumor on or after January 1st, 2019. Participation will last about 18 months, involving the completion of four electronic or paper surveys spaced six months apart. The first survey will take about 40 minutes to complete, while the other three surveys may take about 20 minutes each to complete. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Eryn Beal
(843) 792-7011
bealery@musc.edu

A Phase 1B Dose Escalation Study Of Metabolically Fit CD19 Chimeric Antigen Receptor (CAR) T Cells With CD34 Selection Markers In Adult Patients With Relapsed Or Refractory CD19 B- Cell Non-Hodgkin Lymphoma And Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Date Added
August 16th, 2022
PRO Number
Pro00121846
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Men's Health, Women's Health
Summary

This study is for adult male and female subjects that have been diagnosed with B-cell leukemias and lymphomas. In this research study, some of the subjects immune cells (called T cells) will be taken during a procedure called ‘apheresis', and genetically modified in the laboratory, in order to recognize a protein on the cancer cells. The investigational treatment in this study is called CD19-CD34t metabolically programmed CAR-T cells. The purpose of this study is to test whether these genetically CD19-CD34 CAR T-cells when re-introduced back into the body, will be able to safely and effectively attack the cancer cells. The investigators also want to determine the dose of genetically modified CD19-CD34 CAR T-cells which can be safely administered to subjects. Subjects can expect to be in this study for up to 15 years.

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

Prospective ctDNA Monitoring in Exceptional Responders to Immunotherapy: A Pilot Study

Date Added
August 8th, 2022
PRO Number
Pro00117604
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with advanced cancer. The purpose of this study is to find subjects with advanced cancer that had an exceptional disease response (improvement) while being treated with standard immunotherapy agents. This study will monitor their progression through a series of blood draws. Subjects will either continue immunotherapy or have completed immunotherapy. Participation in the study will take about 6 visits over a period of about 2 years. During this time the study team will follow your care by clinic visit, phone contact and/or medical record review every three months to collect information on the status of your cancer. This is not a treatment study.

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

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Date Added
August 2nd, 2022
PRO Number
Pro00121443
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.

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

A Phase II Open-Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy

Date Added
July 26th, 2022
PRO Number
Pro00118909
Researcher
Theodore Gourdin

List of Studies


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

This study is for subjects that have metastatic urothelial cancer (mUC). Metastatic means your cancer has spread outside the area where it started and has spread to distant parts or organs of the body. This study is testing an "investigational" (not yet Food and Drug Administration, FDA, approved drug) study drug called sacituzumab govitecan. Sacituzumab govitecan is given intravenously, through IV. The primary purpose of this study is to evaluate treatment with sacituzumab govitecan alone and in combination with other treatments namely cisplatin, avelumab and pembrolizumab improves tumor shrinkage. They are antibodies made in a laboratory that blocks signals that the cancer sends to quiet your immune system. By blocking that signal your immune system can see the cancer as foreign and fight it. The subject may remain in the study for 18 months. They may receive additional treatment beyond 18 months if they are tolerating and showing benefit form the treatment.

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

A Phase 1b/2 Study of HCW9218, a Bifunctional TGF-β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer

Date Added
July 26th, 2022
PRO Number
Pro00121308
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

An experimental drug called HCW9218 is being tested in this study. HCW9218 is not approved by the Food and Drug Administration (FDA) or any other health authority for the treatment of cancer or any other disease. Since HCW9218 is experimental, it is only available to people taking part in this study. This study is for participants diagnosed with advanced pancreatic and the disease has spread or cannot be surgically corrected. This is a Phase 1b/2 study, meaning that it is a first in human research study and there is no data on HCW9218 in humans. This study tests different doses of HCW9218 to see which dose is safer in people, how well the treatment is tolerated and whether it has effects on the disease. The study doctor will tell participants which part of this study that they will take part in, the dose escalation phase or dose expansion phase. The dose escalation phase the part of a study that determines the best dose of a new drug or treatment. In a dose-escalation study, the dose of the test drug is increased a little at a time in different groups of people until the highest dose that does not cause harmful side effects is found. In the dose-expansion part of a study allows more participants to receive the study drug to further test the potential side effects of the drug. HCW9218 is given as an injection under the skin (subcutaneous injection). If participants continue in this study, he/she will begin receiving HCW9218 treatment every 28 days. HCW9218 is given as an injection under the skin (subcutaneous injection). For each day participants receive HCW9218, participants will be treated as an outpatient in a treatment center. Participants will be asked to stay in the treatment center for up to 6 hours after the first dose, 3 hours after the second dose, and 30 minutes after subsequent doses, so that the study team can carefully monitor the body's functions and closely watch for potential side effects of the study drug. This study will last about 4 years. Participants will be treated with HCW9218 until disease progression or until they can no longer tolerate the study drug. Participants could be in this study for up to 3 years. There may be risks associated with being treated with HCW9218. Some of the most common side effects that the study doctors know about based on drugs that are similar to HCW9218 are: injection site irritation/ reaction, fatigue/ tiredness, and flu-like symptoms.

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

A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

Date Added
July 1st, 2022
PRO Number
Pro00120871
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with Stage IV or Recurrent Non-small cell lung cancer previously treated with Anti-PD-1 or Anti-PD-L1 therapy. The purpose of this study is to compare the usual treatments to using N-803 (ALT-803) plus pembrolizumab. N-803 (ALT-803) is an experimental drug that may activate someone's natural killer cells so that they can stimulate an immune response to help fight cancer. Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. This immunotherapy drug combination, N-803 (ALT-803) plus pembrolizumab, is not approved by the FDA for use in advanced lung cancer. Participants can expect to be on this study until disease progression, the side effects become too severe, or the participant decides to discontinue the study.

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



-- OR --