Clinical trial NCT03334708: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Pancreatic Diseases
Pancreatitis
Pancreatic Cyst
Keywords: 17-257
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
name: Weill Medical College of Cornell University
name: Weizmann Institute of Science
First posted: 2017-11-07
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects in the PDAC and benign pancreatic disease cohorts will be identified by a member of the patient's treatment team, the principal investigator, or research team at participating institutions. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. The investigator will use information provided by the patient and/or medical record to confirm that the patient is eligible and contact the patient regarding study enrollment. Healthy controls will be recruited from patients from outpatient primary care clinics at non-MSK sites and volunteers from which may include the staffs members at collaborating sites.

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.


Eligibility criteria: Inclusion Criteria:

Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria

* 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 undergo a tumor biopsy
* Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).

Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria

* 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).

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 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 Exclusion Criteria

* 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 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

Primary outcomes:
measure: Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All protocol activities)
state: New Jersey
city: Cold Spring Harbor
country: United States
facility: Cold Springs Harbor Laboratory (Specimen Analysis)
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All protocol activities)
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All protocol activities)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
city: Jerusalem
country: Israel
facility: Sha'are Zedek Medical Center
city: Reẖovot
country: Israel
facility: Weizmann Institute of Science
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References: