A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma



Status:Recruiting
Conditions:Cancer, Cancer, Gastrointestinal, Gastrointestinal, Pancreatic Cancer
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:October 30, 2017
End Date:October 30, 2021
Contact:Kenneth Yu, MD
Email:yuk1@mskcc.org
Phone:646-888-4188

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Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma

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.


Inclusion Criteria:

Advanced Pancreatic Cancer Cohort Inclusion Criteria

- Histological or cytological confirmed diagnosis of locally advanced or metastatic
pancreatic adenocarcinoma by the enrolling institution

- Patient planning to receive systemic treatment

- For stage IV patients, if adjuvant chemotherapy and/or chemoradiation therapy was
received for AJCC Stage I-III pancreatic adenocarcinoma, patients are eligible if the
last systemic therapy was given more than 6 months before initiation of currently
planned systemic therapy

- 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). New tumor biopsies are not required for entrance into
the protocol.

Acute Benign Pancreatic Pathology Control Inclusion Criteria

- 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

Chronic Benign Pancreatic Pathology Control Inclusion Criteria

- 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

IPMN Control Inclusion Criteria

- Confirmed diagnosis of IPMN without high risk features by the enrolling institution

- Hemoglobin > 8

- ECOG performance status 0-2

- A minimum age of 18 years old

Pancreatic Cyst Control Inclusion Criteria

- Confirmed diagnosis of benign pancreatic cyst by the enrolling institution

- Hemoglobin > 8

- ECOG performance status 0-2

- A minimum age of 18 years old

Healthy Control Inclusion Criteria

- ECOG performance status 0-2

- A minimum age of 18 years old

Exclusion Criteria:

Advanced Pancreatic Cancer Cohort Exclusion Criteria

- Prior therapy for advanced/metastatic disease

- Adjuvant therapy for resected disease within the last 6 months

- Active second malignancy

- Any medical or psychiatric condition that may interfere with ability to comply with
protocol procedures

Acute Benign Pancreatic Pathology Control Exclusion Criteria

- 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

Chronic Benign Pancreatic Pathology Control Exclusion Criteria

- 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 Control Exclusion Criteria

- 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

Pancreatic Cyst Control Exclusion Criteria

- 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

Healthy Control Exclusion Criteria

- 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
We found this trial at
3
sites
Jerusalem, 91031
Phone: 646-497-2600
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Jerusalem,
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4188
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10065
Phone: 212-746-6565
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New York, NY
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