A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
NCT ID: NCT03334708
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2017-10-30
2026-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Locally Advanced or Metastatic Pancreatic Cancer Cohort
For patients with locally advanced or metastatic PDAC, blood will be collected pre-treatment initiation (baseline), after first chemotherapy cycle, every 8-12 weeks while under treatment to coincide with restaging CT scan and at time of disease progression.
Blood Draw
If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria:
Patients and controls weighing 50kg or more
* For draw amounts up to 50mL, there is no required hemoglobin threshold.
* For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period.
Patients and controls weighing \< 50kg
* For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.
Tumor Tissue Collection
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Acute Benign Pancreatic Pathology Control Cohort
For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter
Blood Draw
If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria:
Patients and controls weighing 50kg or more
* For draw amounts up to 50mL, there is no required hemoglobin threshold.
* For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period.
Patients and controls weighing \< 50kg
* For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.
Tumor Tissue Collection
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl
For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months.
Blood Draw
If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria:
Patients and controls weighing 50kg or more
* For draw amounts up to 50mL, there is no required hemoglobin threshold.
* For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period.
Patients and controls weighing \< 50kg
* For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.
Tumor Tissue Collection
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Cyst Fluid
Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Healthy Control
For normal controls, blood specimens will be drawn once at study baseline.
Blood Draw
If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria:
Patients and controls weighing 50kg or more
* For draw amounts up to 50mL, there is no required hemoglobin threshold.
* For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period.
Patients and controls weighing \< 50kg
* For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.
Interventions
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Blood Draw
If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria:
Patients and controls weighing 50kg or more
* For draw amounts up to 50mL, there is no required hemoglobin threshold.
* For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period.
Patients and controls weighing \< 50kg
* For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.
Tumor Tissue Collection
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Cyst Fluid
Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Eligibility Criteria
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Inclusion Criteria
* Patient planning to receive systemic treatment
* Hemoglobin \> 8
* ECOG performance status 0-2
* A minimum age of 18 years old
* Willing to undergo a tumor biopsy
* Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).
* Radiological, histological or cytological confirmed diagnosis of pancreatic adenocarcinoma by the enrolling institution
* Patient planned to undergo upfront resection
* No pre-operative systemic therapy nor chemoradiation therapy planned
* Hemoglobin \> 8
* ECOG performance status 0-2
* A minimum age of 18 years old
* Willing to undergo a tumor biopsy
* Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).
* Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology by the enrolling institution
* Hemoglobin \> 8
* ECOG performance status 0-2
* A minimum age of 18 years old
* Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic pathology by the enrolling institution
* Hemoglobin \> 8
* ECOG performance status 0-2
* A minimum age of 18 years old
* Confirmed diagnosis of IPMN without high risk features by the enrolling institution
* A minimum age of 18 years old
* Confirmed diagnosis of benign pancreatic cyst by the enrolling institution
* A minimum age of 18 years old
* A minimum age of 18 years old
Exclusion Criteria
* Active second malignancy, unless low grade malignancy
* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
* Neoadjuvant chemotherapy or radiation therapy is planned
* Active second malignancy, unless low grade malignancy
* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
* Active or prior malignancy, except prior non-melanoma skin cancer
* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
* Active or prior malignancy, except prior non-melanoma skin cancer
* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
* IPMN with high risk features or planned resection
* Active or prior malignancy, except prior non-melanoma skin cancer
* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
* Active or prior malignancy, except prior non-melanoma skin cancer
* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
* Active or prior malignancy, except prior non-melanoma skin cancer
* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
18 Years
ALL
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Weill Medical College of Cornell University
OTHER
Weizmann Institute of Science
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Locations
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Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, United States
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States
New York University
New York, New York, United States
Memorial Sloan - Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Basking Ridge (All protocol activities)
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States
Sha'are Zedek Medical Center
Jerusalem, , Israel
Weizmann Institute of Science
Rehovot, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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Central Contacts
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David Kelson, MD
Role: CONTACT
Facility Contacts
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Kenneth Yu, MD, M.Sc.
Role: primary
Kenneth Yu, MD, M.Sc.
Role: primary
David Tuveson, MD, PhD
Role: primary
Kenneth Yu, MD, M.Sc.
Role: primary
Kenneth Yu, MD, M.Sc.
Role: primary
Kenneth Yu, MD
Role: primary
Kenneth Yu, MD, M.Sc.
Role: primary
S
Role: backup
David Lyden, MD
Role: primary
Kenneth Yu, MD, M.Sc.
Role: primary
Ephrat Levy-Lahad, PhD
Role: primary
Avigdor Scherz, PhD
Role: primary
Talia Golan, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-527
Identifier Type: -
Identifier Source: org_study_id
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