Clinical trials: sponsored by UNC Lineberger Comprehensive Cancer Center
Overweight and Obesity, Overweight
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
The purpose of this pilot study is to conduct a 12-week pilot feasibility study testing usability of a reinforcement learning model (AdaptRL) in a weight loss intervention (ADAPT study).
- Conditions
- Overweight and Obesity, Overweight, Obesity
- Trial name
- NCT05751993
- Testing
- ADAPT
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Cervical Cancer, CIN2
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among…
- Conditions
- Cervical Cancer, CIN2, CIN3, Human Immunodeficiency Virus
- Trial name
- ACT 2 (NCT05413811)
- Testing
- 5 Fluorouracil (5 FU) Cream
- Where
- South Africa
- Volunteers
- 180 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Tumor, Solid, Pancreatic Cancer
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.
- Conditions
- Tumor, Solid, Pancreatic Cancer, Melanoma
- Trial name
- NCT03454035
- Testing
- Ulixertinib, Palbociclib
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer
A Novel Approach Utilizing Organ Specific Age Proteomics
This study compares changes in P16INK4A expression and plasma proteomic signatures of specific organ age pre- and post-chemotherapy in women treated with adjuvant chemotherapy for early-stage breast cancer.
- Trial name
- NCT06789653
- Testing
- p16INK4a mRNA level assessment, organ-specific protein signatures assessment
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Cervix Cancer, Screen HPV-positive
Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina
The purpose of this study is to test the feasibility and acceptability of a multi-level, community-engaged intervention to increase access to cervical cancer screening using human papillomavirus (HPV) self-collection (HPVSC)…
- Trial name
- NCT07294066
- Testing
- Human papilloma virus screening
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Testicular Cancer, Testis Cancer
Virtual Testis Cancer Lay Support and Survivorship Aim 2
This study examines how virtual support can enhance well-being and survivorship in men with testicular cancer. Participants in North Carolina will be randomized into two groups: one with access to a virtual support platform and…
- Trial name
- VITALSS (NCT06702592)
- Testing
- Virtual support, Patient educational material
- Where
- United States
- Volunteers
- 360 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Brain Metastases, Neurocognitive Deficit
MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets
Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration…
- Conditions
- Brain Metastases, Neurocognitive Deficit, White Matter Alterations, Radiation Exposure
- Trial name
- NCT04073966
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Hematologic Malignancies, Lymphoma
DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics
The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and…
- Conditions
- Hematologic Malignancies, Lymphoma, Multiple Myeloma, Leukemia
- Trial name
- DISCOVERY (NCT06296368)
- Testing
- Preference Reporting to Improve Management and Experience (PRIME)
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Hepatocellular Carcinoma (HCC)
Streamlined Resin Y90 Radiation Segmentectomy for Small HCC
This single-arm feasibility study evaluating the safety and efficacy of streamlining Yttrium-90 (Y90) radioembolization workflow for patients with small Hepatocellular Carcinoma (\<5cm) that have no aggressive features on…
- Trial name
- One&Done (NCT06618300)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Hodgkin Lymphoma, Relapse
ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting.
- Conditions
- Hodgkin Lymphoma, Relapse, Refractory
- Trial name
- NCT06090864
- Testing
- Chemotherapy, Cell infusion
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors
This Phase II hybrid decentralized multicenter study examines the outcomes of stopping Bruton tyrosine kinase inhibitor (BTKi) therapy in patients with chronic lymphocytic leukemia (CLL) who have remained in remission for at…
- Trial name
- STOP-CLL-DCT (NCT07526597)
- Testing
- Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Leukemia, Acute Leukemia
Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)
Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies.
- Conditions
- Leukemia, Acute Leukemia, Acute Lymphoid Leukemia, Lymphoblastic Lymphoma
- Trial name
- STEP-ALL (NCT07634653)
- Testing
- Exercises
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Lymphoma, Lymphoma, B-Cell
Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma
This research study combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been…
- Conditions
- Lymphoma, Lymphoma, B-Cell, Immune System Diseases, Immunoproliferative Disorders
- Trial name
- NCT03696784
- Testing
- iC9-CAR19 T cells, Bendamustine, Fludarabine
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Multicentric Castleman Disease
Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi
The purpose of this study is to determine the safety and efficacy of first-line, risk-stratified Rituximab-based Multicentric Castleman Disease (MCD) treatment in Malawi in a single-arm, phase II clinical trial.
- Trial name
- NCT04585893
- Testing
- Rituximab, Etoposide
- Where
- Malawi
- Volunteers
- 15 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Lymphoma, Adult T-Cell Leukemia/Lymphoma
BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma
Adult T-cell leukemia/lymphoma (ATLL) is a rare form of cancer found mostly among people from the Caribbean islands, Western Africa, Brazil, Iran, and Japan.
- Conditions
- Lymphoma, Adult T-Cell Leukemia/Lymphoma, Lymphatic Diseases
- Trial name
- NCT03264131
- Testing
- Brentuximab Vedotin, CHEP
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer, Relapse
Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC).
- Conditions
- Breast Cancer, Relapse, Resistant Cancer, Triple Negative Breast Cancer
- Trial name
- NCT06347068
- Testing
- iC9-CAR.B7-H3 T Cell Therapy, cyclophosphamide, fludarabine
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer
Comparison of CE-DBT and MRI in Patients With Known Breast Lesions
The purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (CE- DBT) and contrast enhanced dynamic magnetic…
- Trial name
- NCT05754749
- Testing
- Iohexol 350 Mg/mL Injectable Solution
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Thoracic
Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
This is a single-site, non-randomized study on the outcomes of remote real-time "ePRO monitoring" in thoracic surgery patients. ePRO monitoring is a health information technology intervention comprised of delivering longitudinal…
- Trial name
- NCT06075316
- Testing
- Symptom monitoring
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Solid Tumor Malignancies, Metastatic Cancer
PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid…
- Conditions
- Solid Tumor Malignancies, Metastatic Cancer, Breast Cancer, Colorectal Cancer
- Trial name
- PROGRESS (NCT06896162)
- Testing
- Expert Review, Blood or tissue samples collection., The Precision Oncology Navigation
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Malignancy, Immune System Diseases
Immuno-Oncology Database and Bioregistry
Immunotherapy, especially immune checkpoint inhibitors (ICIs), are effective in treating many different types of cancers. ICIs fight cancer by driving the immune system into an "activated state" that makes it harder for tumor…
- Conditions
- Malignancy, Immune System Diseases, Autoimmune Diseases
- Trial name
- IOG (NCT04656873)
- Testing
- Biospecimen Collection, Medical Chart Review, Questionnaires/Surveys
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center