Pancreas Cancer Clinical Trial
Official title:
Exoluminate Study: Observational Registry Study to Assess Exo-PDAC Assay Performance for Detection of Pancreatic Adenocarcinoma (PDAC) in High-Risk or Clinically Suspicious Patients
ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC). Those with elevated risk for PDAC can include individuals with intraductal papillary mucinous neoplasms, family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, and a personal or family history of pancreatitis. The goal of the study is to compare the performance of ExoVerita™ assay in early detection of PDAC to current standard-of-care methods of surveillance.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years old. - Meeting criteria for one of the study cohorts. - Capable of giving informed consent. - Able to provide a blood sample. Exclusion Criteria: - < 18 years old. - Pregnancy. - Active cancer (other than pancreatic cancer) and/or undergoing treatment for an active cancer diagnosis (except for skin malignancies). - Prior organ transplant or bone marrow transplant. - History of fainting or other adverse effects when blood is drawn. - Any condition that, in the opinion of the investigator, should preclude enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | University of Florida | Gainesville | Florida |
United States | University of California, San Diego | La Jolla | California |
United States | Bhanu Visvalingam | Port Orange | Florida |
United States | Biological Dynamics | San Diego | California |
United States | Saint John's Cancer Institute at Providence Saint John's Health Center | Santa Monica | California |
United States | Dr. Lomis Comprehensive Surgical Center | Van Nuys | California |
United States | MedStar Health Research Institute | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Biological Dynamics | Dana-Farber Cancer Institute, Medical College of Wisconsin |
United States,
Hinestrosa JP, Kurzrock R, Lewis JM, Schork NJ, Schroeder G, Kamat AM, Lowy AM, Eskander RN, Perrera O, Searson D, Rastegar K, Hughes JR, Ortiz V, Clark I, Balcer HI, Arakelyan L, Turner R, Billings PR, Adler MJ, Lippman SM, Krishnan R. Early-stage multi-cancer detection using an extracellular vesicle protein-based blood test. Commun Med (Lond). 2022 Mar 17;2:29. doi: 10.1038/s43856-022-00088-6. eCollection 2022. — View Citation
Hinestrosa JP, Sears RC, Dhani H, Lewis JM, Schroeder G, Balcer HI, Keith D, Sheppard BC, Kurzrock R, Billings PR. Development of a blood-based extracellular vesicle classifier for detection of early-stage pancreatic ductal adenocarcinoma. Commun Med (Lond). 2023 Oct 19;3(1):146. doi: 10.1038/s43856-023-00351-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical performance of ExoVerita™ assay | Specificity | 36 months or until diagnostic resolution | |
Secondary | Clinical performance of ExoVerita™ assay | Sensitivity | 36 months or until diagnostic resolution | |
Secondary | Stage Shift | Evaluation of stage distribution (SEER) at diagnosis | 36 months or until diagnostic resolution |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05435053 -
Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Recruiting |
NCT06065891 -
Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
|
N/A | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05048524 -
Peri-operative SLOG for Localized Pancreatic Cancer
|
Phase 2 | |
Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
Recruiting |
NCT05679674 -
Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer
|
N/A | |
Recruiting |
NCT05501379 -
Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
|
||
Recruiting |
NCT04851106 -
Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
|
||
Enrolling by invitation |
NCT04466189 -
Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy
|
||
Terminated |
NCT01313416 -
Gemcitabine and CT-011 for Resected Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT01411072 -
Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer
|
N/A | |
Active, not recruiting |
NCT01448668 -
Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)
|
N/A | |
Completed |
NCT01155882 -
Registry Study - Whipple at the Splenic Artery
|
||
Recruiting |
NCT04970056 -
Pancreatic Cancer Early Detection Consortium
|
||
Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 | |
Withdrawn |
NCT03682744 -
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
|
Phase 1 | |
Recruiting |
NCT06036563 -
Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
|