A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03334708
• Other study ID #: 17-527
• Status: Recruiting
• Start date: October 30, 2017
• Est. completion date: October 30, 2024

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kenneth Yu, MD
• Phone: 646-888-4188
• Email: yuk1[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 in any setting

• Prior history of another malignancy

• Active second 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

• 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

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Cyst
• Pancreatic Diseases
• Pancreatitis

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Israel	Sha'are Zedek Medical Center	Jerusalem
Israel	Weizmann Institute of Science	Re?ovot
Israel	Sheba Medical Center	Tel Hashomer
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	Memorial Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All protocol activities)	Montvale	New Jersey
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	New York University	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

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Sheba Medical Center, Weill Medical College of Cornell University, Weizmann Institute of Science

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer		4 years

External Links

•   Memorial Sloan Kettering Cancer Center