9000 Participants Needed

Pancreatic Cancer Screening for Pancreatic Cancer

(CAPS5 Trial)

Recruiting at 8 trial locations
HC
Overseen ByHilary Cosby, RN
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is overseen by Johns Hopkins clinical research office. Team members at each location will report any major issues to the lead researcher.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the CA19-9 test safe for humans?

The CA19-9 test, used as a marker for pancreatic cancer, is generally safe for humans as it involves measuring a substance in the blood. However, it is not always accurate, as it can give false positive or negative results, especially in people with certain genetic traits.12345

How does this treatment for pancreatic cancer differ from other treatments?

This treatment is unique because it focuses on using glycan-based biomarkers, specifically sialyl-Lewis A (sLeA) and sialyl-Lewis X (sLeX), to improve the detection and classification of pancreatic cancers. Unlike the standard CA19-9 biomarker, which is not elevated in about 25% of pancreatic cancer cases, this approach can identify additional cancer cases by detecting related glycans, potentially leading to more accurate diagnosis.12678

What data supports the effectiveness of the treatment CA19-9 for pancreatic cancer screening?

CA19-9 is the most commonly used biomarker for diagnosing pancreatic cancer in symptomatic patients and monitoring therapy, although it has limitations such as false negatives and positives. It is currently the best validated serum tumor marker for pancreatic cancer, despite not being a perfect screening tool.12359

Who Is on the Research Team?

MG

Michael Goggins, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with a scheduled endoscopic evaluation of the pancreas, who either have Hereditary Pancreatitis, Peutz-Jeghers Syndrome, a strong family history of pancreatic cancer, or specific genetic mutations. It's not suitable for those with upper GI tract obstructions, inability to consent, conditions that make endoscopy risky, certain prior surgeries like gastrectomy or if pregnant.

Inclusion Criteria

I have a genetic condition or a strong family history of pancreatic cancer.
I am scheduled for a pancreas examination using an endoscope.

Exclusion Criteria

My health severely limits my daily activities.
I have a blockage in my upper digestive tract that prevents certain medical procedures.
Pregnancy.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pancreatic Surveillance

Participants undergo pancreatic screening and surveillance, including evaluation of pancreatic fluid mutations and circulating pancreatic epithelial cells.

10 years

Follow-up

Participants are monitored for safety and effectiveness after initial screening and surveillance activities.

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • CA19-9
  • Human Synthetic Secretin
  • MRI
  • Secretin
Trial Overview The CAPS5 Study is testing the effectiveness of secretin and tumor marker gene tests (including CA19-9) alongside MRI in detecting pancreatic cancer in high-risk groups. The study will be monitored by Johns Hopkins' quality assurance group and sub-investigators at each site.
How Is the Trial Designed?
9Treatment groups
Active Control
Group I: Group 1 germline mutation carrierActive Control3 Interventions
Group II: Peutz-Jeghers SyndromeActive Control3 Interventions
Group III: Negative controlActive Control1 Intervention
Group IV: Pancreas cyst, IPMN evaluationActive Control1 Intervention
Group V: Chronic PancreatitisActive Control1 Intervention
Group VI: Hereditary pancreatitisActive Control3 Interventions
Group VII: Familial pancreas cancer relativesActive Control3 Interventions
Group VIII: Pancreas cancerActive Control1 Intervention
Group IX: Group 2 germline mutation carrierActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

American Association for Cancer Research

Collaborator

Trials
9
Recruited
830+

ChiRhoClin, Inc.

Industry Sponsor

Trials
10
Recruited
9,900+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Published Research Related to This Trial

CA19-9 is the most validated serum tumor marker for diagnosing pancreatic cancer and monitoring treatment, but it has limitations such as false negatives in individuals with the Lewis (a-b-) genotype and false positives in benign conditions.
Despite the emergence of many potential biomarkers for pancreatic cancer, none have proven to be as effective as CA19-9, which remains the only clinically used marker despite its moderate positive predictive value of 72.3%.
CA 19-9: Biochemical and Clinical Aspects.Scarร , S., Bottoni, P., Scatena, R.[2022]
A new panel of glycan biomarkers, including sialyl-Lewis X and a sialylated form of type 1 N-acetyl-lactosamine, shows improved diagnostic accuracy for pancreatic cancer compared to the traditional CA19-9 antigen, achieving 85% sensitivity and 90% specificity in a study of 200 subjects.
This new biomarker panel outperforms CA19-9, which has a sensitivity of only 54% and a specificity of 86%, highlighting its potential for better early detection of pancreatic cancer in distinct patient subsets.
Glycans related to the CA19-9 antigen are elevated in distinct subsets of pancreatic cancers and improve diagnostic accuracy over CA19-9.Tang, H., Partyka, K., Hsueh, P., et al.[2019]
Lewis-negative pancreatic cancer patients (5-10% of individuals) have a poorer prognosis, with higher metastatic rates and lower CA19-9 expression compared to Lewis-positive patients, based on a study of 853 patients.
Molecular analysis revealed that Lewis-negative cancer cells exhibit higher proliferation and migration rates, along with distinct morphological features, indicating they represent a more aggressive form of pancreatic cancer.
Lewis antigenโ€‘negative pancreatic cancer: An aggressive subgroup.Liu, C., Deng, S., Jin, K., et al.[2021]

Citations

CA 19-9: Biochemical and Clinical Aspects. [2022]
Glycans related to the CA19-9 antigen are elevated in distinct subsets of pancreatic cancers and improve diagnostic accuracy over CA19-9. [2019]
Lewis antigenโ€‘negative pancreatic cancer: An aggressive subgroup. [2021]
Optimize CA19-9 in detecting pancreatic cancer by Lewis and Secretor genotyping. [2018]
Preparation of pancreatic cancer-associated mucin expressing CA19-9, CA50, Span-1, sialyl SSEA-1, and Dupan-2. [2019]
Sialyl Lewis(a) ganglioside in pancreatic cancer tissue correlates with the serum CA 19-9 level. [2019]
Diverse monoclonal antibodies against the CA 19-9 antigen show variation in binding specificity with consequences for clinical interpretation. [2021]
Roles of CA19-9 in pancreatic cancer: Biomarker, predictor and promoter. [2023]
Glycan motif profiling reveals plasma sialyl-lewis x elevations in pancreatic cancers that are negative for sialyl-lewis A. [2021]
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