Clinical trial

The Cancer of the Pancreas Screening-5 CAPS5)Study

NCT02000089

Name

NA_00087754

Description

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.

Trial arms

Trial start

2014-01-06

Estimated PCD

2024-10-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Secretin

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.

Arms:

Chronic Pancreatitis, Familial pancreas cancer relatives, Group 1 germline mutation carrier, Group 2 germline mutation carrier, Hereditary pancreatitis, Negative control, Pancreas cancer, Pancreas cyst, IPMN evaluation, Peutz-Jeghers Syndrome

Other names:

ChiRhoStim

MRI

MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.

Arms:

Familial pancreas cancer relatives, Group 1 germline mutation carrier, Group 2 germline mutation carrier, Hereditary pancreatitis, Peutz-Jeghers Syndrome

Other names:

MRCP

Tumor marker gene test with CA19-9

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.

Arms:

Familial pancreas cancer relatives, Group 1 germline mutation carrier, Group 2 germline mutation carrier, Hereditary pancreatitis, Peutz-Jeghers Syndrome

Size

7000

Primary endpoint

Evaluate pancreatic juice for early cancer markers.

10 years

Eligibility criteria

Inclusion Criteria: * 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, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC * Endoscopic evaluation of pancreas scheduled Exclusion Criteria: * 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 * Inability to provide informed consent * Pregnancy.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Evaluation of the effect of diagnostic tests for pancreatic cancer', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking of the diagnostic test results'}}, 'enrollmentInfo': {'count': 7000, 'type': 'ESTIMATED'}}

Updated at

2024-03-18

1 organization

1 product

5 indications

Organization

Johns Hopkins University

Product

Secretin

Indication

Pancreatic Cancer

Indication

Peutz-Jeghers Syndrome

Indication

Gene Mutation

Indication

Germline Mutation

Indication

Lynch syndrome