Pancreatic CancerNCT03334708
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
An observational study of Pancreatic Cancer and Pancreatic Diseases, run by Memorial Sloan Kettering Cancer Center at 13 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Diseases, Pancreatitis
- What is being tested?
- Blood Draw, Tumor Tissue Collection and Cyst Fluid
- How many people
- 120 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 30 Oct 2017to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 33Show fewer
- 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 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
David Kelson, MD contact
13 sites in 2 countries
United States10 sites, 9 recruiting
- Not yet recruiting
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, 11724
David Tuveson, MD, PhD, 516-367-5246
- Recruiting
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, 11725
Kenneth Yu, MD, M.Sc., 646-888-4188
- Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Kenneth Yu, MD, M.Sc., 646-888-4188
- Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Kenneth Yu, MD, M.Sc., 646-888-4188
- Recruiting
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Kenneth Yu, MD, M.Sc., 646-888-4188
- Active, not recruiting
New York University
New York, New York, 10010
- Recruiting
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
Kenneth Yu, MD, 646-888-4188
- Recruiting
Memorial Sloan Kettering Basking Ridge (All protocol activities)
New York, New York, 10065
Kenneth Yu, MD, M.Sc., 646-888-4188
S
- Not yet recruiting
Weill Cornell Medical Center
New York, New York, 10065
David Lyden, MD, 212-746-6565
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
Kenneth Yu, MD, M.Sc., 646-888-4188
Israel3 sites, 3 recruiting
- Not yet recruiting
Sha'are Zedek Medical Center
Jerusalem, 91031
Ephrat Levy-Lahad, PhD, 646-497-2600
- Not yet recruiting
Weizmann Institute of Science
Rehovot
Avigdor Scherz, PhD, 972 8-934-2111
- Recruiting
Sheba Medical Center
Tel HaShomer
Talia Golan, MD, 03-5303295
About this study
Official title: Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
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.
- Conditions
- Pancreatic Cancer, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst
- Being tested
- Blood Draw, Tumor Tissue Collection, Cyst Fluid
- Keywords
- 17-257
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawDiagnostic test
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 CollectionDiagnostic test
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Cyst FluidDiagnostic test
Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start30 Oct 2017
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center, Weill Medical College of Cornell University, Weizmann Institute of Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334708
- Sponsor's protocol ID
- 17-527
- Status last verified
- Aug 2026
- First submitted
- 1 Nov 2017
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03334708
- Acronym / sponsor ID
- 17-527
- Conditions
- Pancreatic Cancer, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst
- Keywords
- 17-257
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Sheba Medical Center, Weill Medical College of Cornell University, Weizmann Institute of Science
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Advanced PDAC cohort | – | Diagnostic Test: Blood Draw, Diagnostic Test: Tumor Tissue CollectionBlood 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. |
| Cohort 2: Operable PDAC cohort | – | Diagnostic Test: Blood Draw, Diagnostic Test: Tumor Tissue CollectionBlood samples will be drawn from patients prior to operation. Tissue from surgical sample may be analyzed (ATAC-Array) (optional). This cohort is actively accruing. |
| Cohort 3: Acute Benign Pancreatic Pathology Cohort | – | Diagnostic Test: Blood DrawBlood 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. |
| Cohort 4: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts | – | Diagnostic Test: Blood Draw, Diagnostic Test: Cyst FluidBlood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual. |
| Cohort 5: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts | – | Diagnostic Test: Blood Draw, Diagnostic Test: Cyst FluidBlood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual. |
| Cohort 6: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts | – | Diagnostic Test: Blood Draw, Diagnostic Test: Cyst FluidBlood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual. |
| Cohort 7: Healthy Controls | – | Diagnostic Test: Blood DrawBlood samples will be collected at study enrollment only. This cohort is closed to accrual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (33 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawIf 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 | Cohort 1: Advanced PDAC cohort, Cohort 2: Operable PDAC cohort, Cohort 3: Acute Benign Pancreatic Pathology Cohort, Cohort 4: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts, Cohort 5: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts, Cohort 6: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts, Cohort 7: Healthy Controls |
| Tumor Tissue CollectionTumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere | Diagnostic test | Cohort 1: Advanced PDAC cohort, Cohort 2: Operable PDAC cohort |
| Cyst FluidCyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere | Diagnostic test | Cohort 4: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts, Cohort 5: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts, Cohort 6: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts |
Primary outcome
Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Kelson, MD contact
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Pancreatic Diseases, run by Memorial Sloan Kettering Cancer Center at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Yu, MD (646-888-4188, yuk1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.