The Cancer of the Pancreas Screening-5 CAPS5)Study

ConditionsPancreas Cancer Peutz-Jeghers Syndrome (PJS)Gene Mutation Germline Mutation Carrier Lynch Syndrome

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorJohns Hopkins University

About this trial

Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hereditary Pancreatitis or

Peutz-Jeghers Syndrome or

Strong family history of pancreas cancer on one side of the family tree or

Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR

Disqualifiers

Medical comorbidities or coagulopathy that contraindicate endoscopy

Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis

Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope

Poor performance status

Trial design

Design model

Single group

Treatments tested in this trial

Secretin
Drug
inject Secretin to stimulate pancreatic digestive fluid, which is collected in duodenum near ampulla via endoscope suction port. This fluid will be assessed for biomarkers.
MRI
Diagnostic test
MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
Tumor marker gene test with CA19-9
Other intervention
A tumor marker gene test that will be used to stratify individuals into one of several circulating tumor marker reference ranges for CA19-9. The variants in the genes FUT3 and FUT2 affect the levels of CA19-9.

Treatment groups

9,000 Participants

are divided into 9 treatment groups

Treatment groups

See each treatment group below.

Group A: Familial pancreas cancer relativesActive comparator 3 interventions

Group B: Group 1 germline mutation carrierActive comparator 3 interventions

Group C: Group 2 germline mutation carrierActive comparator 3 interventions

Group D: Hereditary pancreatitisActive comparator 3 interventions

Group E: Peutz-Jeghers SyndromeActive comparator 3 interventions

Group F: Negative controlActive comparator 1 intervention

Group G: Chronic PancreatitisActive comparator 1 intervention

Group H: Pancreas cancerActive comparator 1 intervention

Group I: Pancreas cyst, IPMN evaluationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Evaluate pancreatic juice for early cancer markers.

Aim #1: To evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls.

Time frame

10 years

Secondary outcomes

Compare pancreas juice with pancreas cyst fluid

Aim #2: To compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance.

Time frame

10 years

Other outcomes

Time disease progression and prevalence

Aim #3: To determine the prevalence of pancreatic lesions, pancreatic fluid mutations and circulating pancreatic epithelial cells among a large cohort of high-risk individuals undergoing pancreatic screening and surveillance of a new cohort in which screening is begun at age \>55.

Time frame

10 years

Diagnostic performance of a tumor marker gene test for CA19-9 interpretation

Aim #4 To evaluate the diagnostic performance of a tumor marker gene test to personalize the normal reference range of tumor markers such as CA19-9 for patients undergoing pancreatic surveillance.

Time frame

5 years