Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
ConditionPancreatic Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
OR 2+ affected first degree relatives [(FDR), defined as blood related parents, siblings, or children]
CDKN2A/p16, Peutz-Jeghers syndrome (PJS) serine/threonine kinase 11 (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53
Disqualifiers
Is unable to provide informed consent
Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma)
Current or prior history of PDAC or total pancreatectomy
Is currently a prison inmate
Trial population
Patients with pancreatic ductal adenocarcinoma (PDAC) family history, PDAC related genetic mutations or high risk or worrisome pancreatic cysts
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
30,000 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer
Assessed by the number of specimens collected for subjects at right risk for pancreatic cancer due to a strong family history, a mutation in a known pancreatic cancer predisposition gene, or Fukuoka worrisome or high-risk pancreatic cysts.
Time frame
Baseline (at enrollment)2
Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes
Participants will be followed until study completion, defined as when one or more of the following occur: * Subject has provided a pre-treatment biospecimen after diagnosis with pancreatic ductal adenocarcinoma (PDAC) or it has been determined that collection of a pre-treatment biospecimen sample after PDAC diagnosis is infeasible. * Enrollment cyst determined to not be mucinous and thus not worthy of ongoing surveillance. * Subject has had a complete pancreatectomy. * Subject has died. * Study funding has ended
Time frame
Up to study completion, as defined in descriptionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov