Developing a blood test for early diagnosis of pancreatic cancer

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

This study is trying to develop a simple blood test to help find pancreatic cancer early and track how well treatments are working for patients.

Quick facts

• Study type: Observational
• Enrollment: 700 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 13 sites (Middletown, New Jersey and 12 other locations)
• Trial ID: NCT03334708 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a minimally invasive blood-based test to diagnose pancreatic cancer at its early stages and to monitor treatment responses. It involves collecting blood samples, tumor tissue, and cyst fluid from patients diagnosed with pancreatic adenocarcinoma. The study includes two cohorts: one for patients with advanced cancer planning to receive systemic treatment and another for operable patients scheduled for surgery. The goal is to identify biomarkers that can aid in early detection and management of the disease.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed pancreatic adenocarcinoma, either locally advanced or operable, who are willing to undergo biopsies.

Not a fit: Patients with pancreatic cancer who are not eligible for biopsy or those with other severe health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and better monitoring of pancreatic cancer, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using blood-based biomarkers for cancer diagnosis, suggesting that this approach may be viable.

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

Where this trial is running

Middletown, New Jersey and 12 other locations

• Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Bergen (All protocol activities) — Montvale, New Jersey, United States (Recruiting)
• Cold Springs Harbor Laboratory (Specimen Analysis) — Cold Spring Harbor, New York, United States (Not_yet_recruiting)
• Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
• Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York, United States (Recruiting)
• New York University — New York, New York, United States (Active_not_recruiting)
• Memorial Sloan - Kettering Cancer Center — New York, New York, United States (Recruiting)
• Memorial Sloan Kettering Basking Ridge (All protocol activities) — New York, New York, United States (Recruiting)
• Weill Cornell Medical Center — New York, New York, United States (Not_yet_recruiting)
• Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre, New York, United States (Recruiting)
• Sha'are Zedek Medical Center — Jerusalem, Israel (Not_yet_recruiting)
• Weizmann Institute of Science — Rehovot, Israel (Not_yet_recruiting)
• Sheba Medical Center — Tel Litwinsky, Israel (Recruiting)

Study contacts

• Study coordinator: Kenneth Yu, MD

Conditions Pancreatic Cancer; Pancreatic Diseases; Pancreatitis; Pancreatic Cyst; 17-257