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Pancreatic NeoplasmsNCT03250078

A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

An observational study of Pancreatic Neoplasms, run by Nuvance Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
MRI/MRCP
Type of treatment
Injection or infusion
How many people
200 participants
Where
1 siteUnited States
Study dates
Nov 2016to Nov 2030
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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 50-90 years of age. Strong family history of pancreatic cancer/ known genetic mutation

Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the following is required for questions 1-3)

  1. For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.
  2. For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.
  3. The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2, ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with PC.
  4. The individual is at least 50 years old or 10 years younger than the youngest relative with PC.
  5. ECOG Performance Status of 0-1.
  6. No known contraindications to MRI examination or gadolinium contrast.
  7. Willing to undergo MRI and screening for metal implants or metal injury.
  8. Estimated GFR >29 mL/min
  9. Ability to provide informed consent.
  10. Willing to return to study site for all study assessments.

Registration-Exclusion Criteria:

  1. Prior history of pancreatic cancer.
  2. Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
  3. Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
  4. Hereditary pancreatitis.
  5. eGFR < 30 mL/min
  6. Contraindication to MRI examination or gadolinium contrast.
  7. Pregnant or nursing women.
  8. Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tammy Lo, APRN contact

Tammy.Lo@nuvancehealth.org

Pramila Krumholtz, RN contact

Pramila.Krumholtz@nuvancehealth.org

United States1 site, 1 recruiting

  • Nuvance Health

    Norwalk, Connecticut, 06856

    Tammy Lo, APRN, 203-855-3551, Tammy.Lo@nuvancehealth.org

    Pramila Krumholtz, RN, 203-739-7997, Pramila.Krumholtz@nuvancehealth.org

    Recruiting

Other trials in United States

About this study

The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.

Read the detailed description

Individuals 50 years of age and older who have a family history of pancreatic cancer will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed annually for 3 years (4 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The costs of MRI will be covered by the study.

Being tested
MRI/MRCP
Keywords
Pancreas, Cancer, MRI, BRCA, Early Detection, Genetics, ATM, PALB2, Lynch, CDKN2A
Medical subject headings
Pancreatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI/MRCPDiagnostic test

    An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually

Study groups in NCT03250078
Study groupRoleWhat they receive
FAMILIAL PANCREATIC CANCER and/or GENE MUTATIONAn inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.
Receives: Diagnostic Test: MRI/MRCP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early Stage Pancreatic Cancer or Precursor Lesions

    Incidence of Pancreatic Cancer or precursor lesions within a population of individuals with a strong family history of pancreatic cancer or known genetic mutation compared to the expected incidence in the general population.

    Measured: Through study completion, up to 3 years

Secondary outcomes (2)

  1. Serial Pancreatic MRI Screening

    Utility of MRI as a screening tool for Pancreatic Cancer in the study population.

    Measured: Through study completion, up to 3 years

  2. Serum Bio-bank

    Banking serum from participants to isolate circulating exosomes and circulating tumor DNA.

    Measured: Through study completion, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study startNov 2016
  3. Primary completionNov 2030 (estimated)
  4. Study completionNov 2030 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03250078
Sponsor's protocol ID
16-17
Status last verified
Apr 2026
First submitted
16 Nov 2016
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

  • Kandiah J, Lo T, Jin D, Melchior L, Krebs TL, Anand N, Ingram S, Krumholtz P, Pandya D, Trinidad A, Dong XE, Seshadri R, Bauman J, Lee R, Frank RC. A Community-Based Pancreatic Cancer Screening Study in High-Risk Individuals: Preliminary Efficacy and Safety Results. Clin Transl Gastroenterol. 2022 Aug 1;13(8):e00516. doi: 10.14309/ctg.0000000000000516. Epub 2022 Jul 20.

    PubMed 35854467

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Neoplasms, run by Nuvance Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 Tammy Lo, APRN (Tammy.Lo@nuvancehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early Stage Pancreatic Cancer or Precursor Lesions (time frame: Through study completion, up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03250078, which also lists 1 linked publication.

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 13 Apr 2026.

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