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A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334708
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : June 26, 2020
Sponsor:
Collaborators:
Sheba Medical Center
Weill Medical College of Cornell University
Weizmann Institute of Science
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Pancreatic Diseases Pancreatitis Pancreatic Cyst Diagnostic Test: Blood Draw Diagnostic Test: Tumor Tissue Collection Diagnostic Test: Cyst Fluid

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Locally Advanced or Metastatic Pancreatic Cancer Cohort
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.
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.

Diagnostic Test: Tumor Tissue Collection
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Acute Benign Pancreatic Pathology Control Cohort
For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter
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.

Diagnostic Test: Tumor Tissue Collection
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl
For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months.
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.

Diagnostic Test: Tumor Tissue Collection
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Diagnostic Test: Cyst Fluid
Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Healthy Control
For normal controls, blood specimens will be drawn once at study baseline.
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.




Primary Outcome Measures :
  1. Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA

Blood samples will be analyzed for various biomarkers. Initial biomarkers to be tested include proteins and proteases, functional DNA repair assays, exosomes, stromal elements, circular RNAs (cRNA) and circulating tumor DNA (ctDNA).

Tissue will be utilized from already planned. Biopsy tissue is expected to be available for virtually all PDAC patients, occasionally for IPMN and cysts patients, rarely for pancreatitis and never for healthy controls.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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 (i.e. colon, prostrate, breast, etc)
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334708


Contacts
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Contact: Kenneth Yu, MD 646-888-4188 yuk1@mskcc.org
Contact: David Kelson, MD 646-888-4179

Locations
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United States, New York
Cold Springs Harbor Laboratory (Specimen Analysis) Not yet recruiting
Cold Spring Harbor, New York, United States, 11724
Contact: David Tuveson, MD, PhD    516-367-5246      
New York University Recruiting
New York, New York, United States, 10010
Contact: Diane Simeone, MD    212-731-6150      
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Kenneth Yu, MD    646-888-4188      
Weill Cornell Medical Center Not yet recruiting
New York, New York, United States, 10065
Contact: David Lyden, MD    212-746-6565      
Israel
Sha'are Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Ephrat Levy-Lahad, PhD    646-497-2600      
Weizmann Institute of Science Not yet recruiting
Reẖovot, Israel
Contact: Avigdor Scherz, PhD    972 8-934-2111      
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Talia Golan, MD    03-5303295      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Sheba Medical Center
Weill Medical College of Cornell University
Weizmann Institute of Science
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03334708    
Other Study ID Numbers: 17-527
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
17-257
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Cyst
Pancreatitis
Pancreatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Diseases
Cysts