ClinicalTrials.gg
RecruitingNCT03334708Updated Aug 14, 2026

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

An observational study in Pancreatic Cancer, Pancreatic Diseases and Pancreatitis, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 13 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

From the registry’s dates

  • Started Oct 2017; still recruiting 9 years later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic Cancer
  • Pancreatic Diseases
  • Pancreatitis
  • Pancreatic Cyst

Keywords

  • 17-257
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 120 is below the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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 MSK or 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria

  • Radiological, histological or cytological confirmed diagnosis of locally advanced or pancreatic adenocarcinoma by the enrolling institution
  • Patient planning to receive systemic treatment
  • > 8
  • performance status 0-2
  • A minimum age of 18 years old
  • Willing to provide permission to obtain banked tumor tissue for analysis (previous 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 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

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 , 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

  • 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cohort 1: Advanced PDAC cohort

    Blood and sweat samples will be drawn from patients prior to starting treatment. A research biopsy may be performed for tissue analysis (ATAC-Array) (optional). This cohort is actively accruing.

    Diagnostic Test: Blood Draw · Diagnostic Test: Tumor Tissue Collection

  • Cohort 2: Operable PDAC cohort

    Blood samples will be drawn from patients prior to operation. Tissue from surgical sample may be analyzed (ATAC-Array) (optional). This cohort is actively accruing.

    Diagnostic Test: Blood Draw · Diagnostic Test: Tumor Tissue Collection

  • Cohort 3: Acute Benign Pancreatic Pathology Cohort

    Blood samples will be drawn during acute episode of disease and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.

    Diagnostic Test: Blood Draw

  • Cohort 4: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts

    Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.

    Diagnostic Test: Blood Draw · Diagnostic Test: Cyst Fluid

  • Cohort 5: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts

    Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.

    Diagnostic Test: Blood Draw · Diagnostic Test: Cyst Fluid

  • Cohort 6: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts

    Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.

    Diagnostic Test: Blood Draw · Diagnostic Test: Cyst Fluid

  • Cohort 7: Healthy Controls

    Blood samples will be collected at study enrollment only. This cohort is closed to accrual.

    Diagnostic Test: Blood Draw

Interventions

  • Diagnostic testBlood 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 testTumor Tissue Collection

    Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

  • Diagnostic testCyst Fluid

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

06

What researchers measure

Primary outcomes

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

    Time frame: 4 years

07

Study locations

8 of 13 sites recruiting
  • Memorial Sloan Kettering Monmouth (All protocol activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Kenneth Yu, MD, M.Sc. · Contact646-888-4188
  • Memorial Sloan Kettering Bergen (All protocol activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Kenneth Yu, MD, M.Sc. · Contact646-888-4188
  • Cold Springs Harbor Laboratory (Specimen Analysis)
    Cold Spring Harbor, New York 11724, United States
    Not yet recruiting
    • David Tuveson, MD, PhD · Contact516-367-5246
  • Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
    Commack, New York 11725, United States
    Recruiting
    • Kenneth Yu, MD, M.Sc. · Contact646-888-4188
  • Memorial Sloan Kettering Westchester (All protocol activities)
    Harrison, New York 10604, United States
    Recruiting
    • Kenneth Yu, MD, M.Sc. · Contact646-888-4188
  • New York University
    New York, New York 10010, United States
    Active, not recruiting

    Not enrolling at this site.

  • Memorial Sloan - Kettering Cancer Center
    New York, New York 10021, United States
    Recruiting
    • Kenneth Yu, MD · Contact646-888-4188
  • Memorial Sloan Kettering Basking Ridge (All protocol activities)
    New York, New York 10065, United States
    Recruiting
    • Kenneth Yu, MD, M.Sc. · Contact646-888-4188
    • S · Contact
  • Weill Cornell Medical Center
    New York, New York 10065, United States
    Not yet recruiting
    • David Lyden, MD · Contact212-746-6565
  • Memorial Sloan Kettering Nassau (All protocol activities)
    Rockville Centre, New York 11553, United States
    Recruiting
    • Kenneth Yu, MD, M.Sc. · Contact646-888-4188
  • Sha'are Zedek Medical Center
    Jerusalem, 91031, Israel
    Not yet recruiting
    • Ephrat Levy-Lahad, PhD · Contact646-497-2600
  • Weizmann Institute of Science
    Rehovot, Israel
    Not yet recruiting
    • Avigdor Scherz, PhD · Contact972 8-934-2111
  • Sheba Medical Center
    Tel Litwinsky, Israel
    Recruiting
    • Talia Golan, MD · Contact03-5303295
08

References and documents

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Oct 2026, 108 months after the start.

Of 318 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 182. This study's planned 108 months is above that.

Counting every sponsor, half of 352 studies reached it within 60 months; a quarter within 34 and three quarters within 182.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2017
First posted
Nov 7, 2017
StartActual
Oct 30, 2017
Primary completionEst.
Oct 30, 2026
CompletionEst.
Oct 30, 2026
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03334708
Collaborators
Sheba Medical Center, Weill Medical College of Cornell University, Weizmann Institute of Science
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
Oct 30, 2017
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Aug 14, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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