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Pancreatic Cancer Early Detection Consortium

Sponsor: Arbor Research Collaborative for Health

NCT ID: NCT04970056

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 123 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the Arbor Research Collaborative for Health, is a database for people with a higher chance of getting pancreatic cancer, people with pancreatic cysts, and people who have pancreatic cancer. It includes people with family histories of pancreatic cancer or inherited gene changes linked to it. The study aims to collect information and samples (such as blood or saliva) to help with research into finding pancreatic cancer earlier.

Who can take part

  • People aged 50 or over (or around 10 years younger than the earliest pancreatic cancer case in their family) who have close relatives with pancreatic cancer, such as two relatives on the same side of the family or two affected close (first-degree) relatives
  • People aged 50 or over (or around 10 years younger than the earliest family case) with a harmful change in certain genes (BRCA1, BRCA2, PALB2, ATM, or genes linked to bowel cancer or other conditions) who also have a close relative with pancreatic cancer
  • People aged 40 or over with Familial Atypical Moles and Malignant Melanoma (FAMMM) and a harmful CDKN2A gene change
  • People aged 35 or over with Peutz-Jeghers syndrome and a harmful STK11 gene change
  • People aged 40 or over with hereditary pancreatitis and a harmful PRSS1 gene change
  • People aged 50 or over with a harmful ATM, BRCA1, BRCA2 or PALB2 gene change, even with no family history of pancreatic cancer
  • People who had a first-degree relative (parent, sibling or child) diagnosed with pancreatic cancer at age 45 or younger, who are up to 10 years younger than that relative was at diagnosis
  • Younger people who would meet the above criteria but are too young
  • People who do not meet any of the criteria above but are being checked for pancreatic cancer risk
  • People not already having pancreas checks at a study site, including relatives of people in the study, who may be invited to give a sample (blood, saliva or a cheek swab)
  • People who developed pancreatic cancer or pre-cancerous changes after joining the study, with a family history or gene changes as above
  • People with pancreatic cancer or pre-cancerous changes and a family history or gene changes as above, or diagnosed at age 45 or younger
  • People newly diagnosed with early-stage (stage 1 or 2) pancreatic cancer at a study site who do not meet the other cancer criteria
  • People with pancreatic cancer at a study site who do not meet any of the other cancer criteria
  • People with a pancreatic cyst who do not meet any of the other criteria

Who may not be able to

  • People who do not meet any of the criteria listed for the study groups

What taking part involves

  • • This is an observational database study, not a treatment trial. Taking part involves having your information stored in the database and possibly giving a sample such as blood, saliva or a cheek swab for research.

Time commitment: Not stated in detail — ask the trial team about visits, how long taking part lasts, and exactly what is involved.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years to 90 Years
Who
All
Number of participants
20,000
Started
2020-09-18
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for pancreas cancer
  • • Clinical study - 20,000 participants
  • • The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up

Who can take part?

  • • Ages 18 Years to 90 Years
  • • Diagnosed with pancreas cancer

Where?

  • • Liverpool - University of Liverpool

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.

More detail

The main objective of the PRECEDE Consortium is to build a shared resource to drive research in critical areas necessary for early detection and prevention of PDAC. The PRECEDE Consortium is an observational prospective cohort study, with single or serial biosample collection (every 6-12 months) in defined high-risk groups. A standardized procedure for collection and processing of human blood for the PRECEDE Consortium will be applied to all blood samples collected as part of the study. Barcoded samples will be stored at the clinical centers, using the specific labels for the PRECEDE study and corresponding data will be entered into the study database. Clinical data and outcomes will be obtained from institutional databases or clinical records to correlate patient information with laboratory results from biospecimens obtained for research. Patients will be followed by their attending physician and receive the standard follow-up care after the procedure in which biospecimen was obtained. It is the intent that biospecimens will be made available to all consortium investigators.

Pancreas CancerPancreas CystPancreatic Ductal AdenocarcinomaGenetic Predisposition

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 90 Years
  • Who can join: All genders

Biomarkers mentioned

BRCA1BRCA2

What the study is looking for

  • ✓Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the...
  • ✓Cohort 1
  • ✓Individuals without history of PDAC meeting any of the following criteria:
  • ✓2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
  • ✓Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+

Who cannot take part

  • ✗Individuals not meeting the criteria above.
See the full criteria
Inclusion Criteria: Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database: Cohort 1 Individuals without history of PDAC meeting any of the following criteria: 1. 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis. 2. 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family 3. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family 4. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+ 5. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+ 6. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+ Cohort 2 Individuals without history of PDAC meeting any of the following criteria: 1. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+ 2. 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family 3. 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2) Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort. Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort. Cohort 6a Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria: 1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other 2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11 Cohort 6b Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria: 1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other 2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11 3. Diagnosed ≤ age 45 Cohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b. Cohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c. Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk) Exclusion Criteria: * Individuals not meeting the criteria above.

Where Is This Study? (1 UK site)

University of Liverpool

Liverpool, United Kingdom

Recruiting
Site contact (verified)
Bill GreenhalfPrincipal Investigator
Annabelle Bougheyeuropac@liverpool.ac.uk

How to Get in Touch

Naveen Fawas, BS

Sponsor contact

CONTACT

7346654108 naveen.fawaz@arborresearch.org

John Graff, PhD

Sponsor contact

CONTACT

7346654108 john.graff@arborresearch.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-07