Ignite Creation Date:
2025-12-18 @ 8:28 AM
Ignite Modification Date:
2025-12-23 @ 11:16 PM
Study NCT ID:
NCT02781012
Status:
None
Last Update Posted:
2019-04-16 00:00:00
First Post:
2016-05-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project Survival-Prospective Biomarker Discovery
Sponsor:
None
Organization:
Study Overview
Official Title:
Project Survival-Prospective Biomarker Discovery to Transform Diagnosis and Treatment for Patients With Pancreatic Diseases and Cancer
Status:
None
Status Verified Date:
2019-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Primary Objective of this study is to identify and validate biomarkers that can be used for early detection and selection of personalized treatment of pancreatic diseases, including adenocarcinoma and pancreatitis. A maximum of 600 subjects will be enrolled in this study, including healthy volunteers, subjects with acute and chronic pancreatitis, family members at risk for pancreatic cancer (as defined below), and subjects with all stages of pancreatic adenocarcinoma who will contribute samples annotated with longitudinal clinical data. Biomarkers will be investigated for potential as Theranostic, Prognostic, Diagnostic and Therapeutic indicators among subjects with pancreatitis and pancreatic cancer.
Examples of eligible participants include:
* Healthy volunteers without any known pancreatic disease (50 subjects)
* Healthy volunteers with no known benign or malignant pancreatic disease, AND with one first-degree relative with pancreatic cancer, OR two second-degree relatives with pancreatic cancer. These subjects also include those who have undergone surgery for suspected pancreatic cancer, and who are found to have a non-pancreatic cancer pathology upon final local site or central pathology review. (100 subjects).
* Subjects diagnosed acute or chronic pancreatitis (50 subjects).
* Subjects diagnosed with early stage pancreatic cancer who undergo surgery as standard of care therapy with or without preoperative (neoadjuvant) chemotherapy and/or radiation therapy; subjects diagnosed with borderline pancreatic cancer, or subjects diagnosed with locally advanced pancreatic cancer (200 subjects). Enrollment of treatment naïve subjects with early stage pancreatic cancer is preferred.
* Subjects diagnosed with metastatic pancreatic cancer and treated with any standard of care therapies, such as gemcitabine/Abraxane or FOLFIRINOX as front-line treatment with or without associated radiation treatment (200 subjects). Enrollment of treatment naïve subjects with metastatic pancreatic cancer is preferred.
Consented and enrolled subjects will be asked to participate in this study in the following ways:
* Subjects will be asked to contribute blood (serum, buffy coat, and plasma), urine, and saliva after enrollment, and at clinically-significant timepoints throughout their treatment as indicated by their disease state.
* Subjects undergoing surgery for pancreatic disease will also be asked to donate diseased and adjacent non-diseased pancreatic tissue, defined as "excess" tissue from diagnostic or therapeutic biopsy or surgical procedures that is no longer required for standard of care purposes.
* Examples of "excess" tissue after a standard of care surgical procedures include any/all biopsies or resections performed and may include non-diseased pancreatic tissue and pancreatic tumor tissue.
* These collection procedures will not alter or prolong the conduct of standard of care surgical procedures.
Subsequent liquid non-tissue samples will be collected from all subjects at the following clinically-relevant time points related to standard of care treatment for pancreatic disease:
* Before, at the time of, and/or after surgery to remove a pancreatic tumor or inflammatory mass;
* before and after chemotherapy and/or radiation for cancer;
* upon local, regional, or distant progression of cancer;
* resolution of the disease process.
Blood (serum, plasma, and buffy coat), urine and saliva will not be collected more than six (6) times in a 12 month period per subject.
Samples will be collected until the subject withdraws or the study has completed enrollment.
Examples of eligible participants include:
* Healthy volunteers without any known pancreatic disease (50 subjects)
* Healthy volunteers with no known benign or malignant pancreatic disease, AND with one first-degree relative with pancreatic cancer, OR two second-degree relatives with pancreatic cancer. These subjects also include those who have undergone surgery for suspected pancreatic cancer, and who are found to have a non-pancreatic cancer pathology upon final local site or central pathology review. (100 subjects).
* Subjects diagnosed acute or chronic pancreatitis (50 subjects).
* Subjects diagnosed with early stage pancreatic cancer who undergo surgery as standard of care therapy with or without preoperative (neoadjuvant) chemotherapy and/or radiation therapy; subjects diagnosed with borderline pancreatic cancer, or subjects diagnosed with locally advanced pancreatic cancer (200 subjects). Enrollment of treatment naïve subjects with early stage pancreatic cancer is preferred.
* Subjects diagnosed with metastatic pancreatic cancer and treated with any standard of care therapies, such as gemcitabine/Abraxane or FOLFIRINOX as front-line treatment with or without associated radiation treatment (200 subjects). Enrollment of treatment naïve subjects with metastatic pancreatic cancer is preferred.
Consented and enrolled subjects will be asked to participate in this study in the following ways:
* Subjects will be asked to contribute blood (serum, buffy coat, and plasma), urine, and saliva after enrollment, and at clinically-significant timepoints throughout their treatment as indicated by their disease state.
* Subjects undergoing surgery for pancreatic disease will also be asked to donate diseased and adjacent non-diseased pancreatic tissue, defined as "excess" tissue from diagnostic or therapeutic biopsy or surgical procedures that is no longer required for standard of care purposes.
* Examples of "excess" tissue after a standard of care surgical procedures include any/all biopsies or resections performed and may include non-diseased pancreatic tissue and pancreatic tumor tissue.
* These collection procedures will not alter or prolong the conduct of standard of care surgical procedures.
Subsequent liquid non-tissue samples will be collected from all subjects at the following clinically-relevant time points related to standard of care treatment for pancreatic disease:
* Before, at the time of, and/or after surgery to remove a pancreatic tumor or inflammatory mass;
* before and after chemotherapy and/or radiation for cancer;
* upon local, regional, or distant progression of cancer;
* resolution of the disease process.
Blood (serum, plasma, and buffy coat), urine and saliva will not be collected more than six (6) times in a 12 month period per subject.
Samples will be collected until the subject withdraws or the study has completed enrollment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: