A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

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Brief Title

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Official Title

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

Brief Summary

      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.
    



Study Type

Observational


Primary Outcome

Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer


Condition

Pancreatic Cancer

Intervention

Blood Draw

Study Arms / Comparison Groups

 Locally Advanced or Metastatic Pancreatic Cancer Cohort
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

750

Start Date

October 30, 2017

Completion Date

October 30, 2021

Primary Completion Date

October 30, 2021

Eligibility Criteria

        Inclusion Criteria:

        Cohort 1: 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.

        Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria

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

        Cohort 3: 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

        Cohort 4: 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

        Cohort 5: IPMN Control Inclusion Criteria

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

          -  A minimum age of 18 years old

        Cohort 6: Pancreatic Cyst Control Inclusion Criteria

          -  Confirmed diagnosis of benign pancreatic cyst by the enrolling institution

          -  A minimum age of 18 years old

        Cohort 7: Healthy Control Inclusion Criteria

          -  A minimum age of 18 years old

        Exclusion Criteria:

        Cohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria

          -  Prior therapy for advanced/metastatic disease

          -  Prior history of another malignancy

          -  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

          -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
             for genetic predisposition to cancer

        Cohort 2: Operable Pancreatic Cancer Cohort Exclusion Criteria

          -  Neoadjuvant chemotherapy or radiation therapy is planned

          -  Prior history of another malignancy, except non-melanoma skin cancer

          -  Active second malignancy

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

          -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
             for genetic predisposition to cancer

        Cohort 3: 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

        Cohort 4: 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

        Cohort 5: 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

        Cohort 6: 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

        Cohort 7: 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 646-888-4188, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT03334708

Organization ID

17-527


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 Sheba Medical Center

Study Sponsor

, , 


Verification Date

January 2021