What this study is
The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.
What's being tested
- Blood Draw
Intervention · DIAGNOSTIC TEST
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
Intervention · DIAGNOSTIC TEST
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
- Cyst Fluid
Intervention · DIAGNOSTIC TEST
Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Study details
- Official title
- Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Pancreatic Cancer · Pancreatic Diseases · Pancreatitis · Pancreatic Cyst
- Enrolling
- 120 people
- Starts
- 2017-10-30
- Est. completion
- 2026-10-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedCohort 5: IPMN Control
You may qualify if
- Cohort 1: Advanced Pancreatic Cancer Cohort
- Radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution
- Patient planning to receive systemic treatment
- Hemoglobin > 8
- ECOG performance status 0-2
- A minimum age of 18 years old
- Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). Cohort 2: Operable Pancreatic Cancer Cohort
- 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 provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). Cohort 3: Acute Benign Pancreatic Pathology Control
- 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 Cohort 4: Chronic Benign Pancreatic Pathology Control
- 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 Cohort 6: Pancreatic Cyst Control
- Confirmed diagnosis of benign pancreatic cyst by the enrolling institution
- A minimum age of 18 years old
You can't join if
- 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 Cohort 6: Pancreatic Cyst Control
- 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
- Cohort 1: Advanced Pancreatic Cancer Cohort
- Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting
- Active second malignancy, unless low grade malignancy
- Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures Cohort 2: Operable Pancreatic Cancer Cohort
- 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 Cohort 3: Acute Benign Pancreatic Pathology Control
- 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 Cohort 4: Chronic Benign Pancreatic Pathology Control
- 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
Cohort 7: Healthy Control
You may qualify if
- Cohort 1: Advanced Pancreatic Cancer Cohort
- Radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution
- Patient planning to receive systemic treatment
- Hemoglobin > 8
- ECOG performance status 0-2
- A minimum age of 18 years old
- Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). Cohort 2: Operable Pancreatic Cancer Cohort
- 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 provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). Cohort 3: Acute Benign Pancreatic Pathology Control
- 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 Cohort 4: Chronic Benign Pancreatic Pathology Control
- 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
- A minimum age of 18 years old
You can't join if
- 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
- Cohort 1: Advanced Pancreatic Cancer Cohort
- Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting
- Active second malignancy, unless low grade malignancy
- Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures Cohort 2: Operable Pancreatic Cancer Cohort
- 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 Cohort 3: Acute Benign Pancreatic Pathology Control
- 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 Cohort 4: Chronic Benign Pancreatic Pathology Control
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (13)
12 openContact for 7 of 12 open sites
- Kenneth Yu, MD, M.Sc. · Contact646-888-4188
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
RecruitingMemorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States
RecruitingCold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, United States
- David Tuveson, MD, PhD · Contact516-367-5246
Not yet recruitingMemorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, United States
RecruitingMemorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States
RecruitingMemorial Sloan - Kettering Cancer Center
New York, New York, United States
RecruitingMemorial Sloan Kettering Basking Ridge (All protocol activities)
New York, New York, United States
- S · Contact
Recruiting- Not yet recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States
RecruitingNew York University
New York, New York, United States
Active, not recruiting
3 sites outside the US
- Not yet recruiting
- Not yet recruiting
- Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 17-527
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.