Pancreatic Cancer Clinical Trial
Official title:
Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.
This proposed project is designed to collect data and specimens from patients/subjects
presenting to the University of Michigan with a disease affecting the pancreas (or specific
control populations). This protocol is focused on collecting data, blood samples, and tissue
on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts,
pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy
controls.
We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy
coat are collected and stored according to strict SOPs.
The recently funded GI SPORE, here at the University of Michigan, is focused on pancreatic
and colon diseases. This protocol is focused on collecting data, blood samples, and tissue on
subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts,
pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy
controls. A SPORE is an NCI-funded, Specialized Program in Research Excellence, with specific
requirements. Those requirements include 4 projects with a clinical and a basic science Co-PI
and several COREs, including a biospecimen core. Each project that has a human subjects
component will require a separate protocol and IRB submission when those projects are to
begin.
The specific populations we are recruiting are determined by the aims of project 2 and by the
need to create a repository as part of the biospecimen core (please see the grant for details
on the aims of these 2 projects).
A specially designed database is being built for this study to handle the data aspects. Our
collaborators at Dartmouth College have significant experience in managing data as they have
been our partners for our work in the EDRN (PI Brenner). Case report forms and other data
collection tools have been developed and are being used to populate the database. All of the
actual data will be completely deidentified per HIPAA regulations.
We intend to model the data and specimen collection on the model used by our work with the
NCI-EDRN. This includes a customized database, the use of kits with pre-labled, bar-coded
aliquots, and standardized data collection forms (CRFs).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05305001 -
Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
|
||
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
| Recruiting |
NCT06054984 -
TCR-T Cells in the Treatment of Advanced Pancreatic Cancer
|
Early Phase 1 | |
| Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
| Terminated |
NCT03140670 -
Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy
|
Phase 2 | |
| Terminated |
NCT00529113 -
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
|
Phase 1 | |
| Recruiting |
NCT05168527 -
The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients
|
Phase 2 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT05391126 -
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
|
N/A | |
| Terminated |
NCT03300921 -
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT03153410 -
Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas
|
Early Phase 1 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT05679583 -
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT04183478 -
The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer
|
Phase 2/Phase 3 | |
| Terminated |
NCT03600623 -
Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
|
Early Phase 1 | |
| Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
| Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
| Completed |
NCT04290364 -
Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study
|