What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include chemotherapy agents such as gemcitabine and S-1. Gemcitabine is often associated with side effects like nausea, vomiting, diarrhea, fatigue, and low blood counts, which can increase the risk of infection. S-1, an oral fluoropyrimidine, can cause hand-foot syndrome, nausea, and diarrhea. Early detection methods, such as those being studied in the Bluestar Genomics Early-Detection Pancreatic Cancer Test, aim to identify cancer at a stage where less aggressive treatments might be effective, potentially reducing the severity of side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, particularly for advanced stages. Notable approvals include gemcitabine, which has been a standard treatment, and combination therapies such as FOLFIRINOX (a regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin) and gemcitabine plus nab-paclitaxel. These treatments have shown improved survival rates compared to single-agent therapies. While the Bluestar Genomics test focuses on early detection, these systemic therapies are crucial for managing advanced pancreatic cancer once detected.

What other types of research exist?

Promising alternatives to Bluestar Genomics' early-detection pancreatic cancer test include: 1) Detection of circulating circular RNA (hsa_circ_0013587) in blood, 2) Analysis of differentially expressed microRNAs, 3) Multi-biomarker panels using enzyme-linked immunosorbent assays (ELISA), and 4) Next-generation sequencing of pancreatic juice to detect tumor-promoting mutations.

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Cancer Detection Test

Pancreatic Cancer Detection Test for New-Onset Diabetes

N/A

Waitlist Available

Led By Kelly Bethel, MD

Research Sponsored by Bluestar Genomics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No history of pancreatic cancer

≥50 years of age or older at the time of enrollment

Must not have

History or presence of HIV/AIDs, Hepatitis A or E within the past five years, TB, any kind of prion disorder (e.g., CJD)

Any known pancreatic lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months or until diagnostic resolution

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new blood test to find hidden pancreatic cancer in people aged 50 or older who have been diagnosed with type II diabetes. The test looks for cancer signals in the blood, and if found, an MRI scan is done to confirm the presence of cancer.

Who is the study for?

This trial is for people over 50 with new-onset type II diabetes who have never had pancreatic cancer or certain other pancreatic diseases. Participants must not have a history of any active cancers in the past five years (except some skin cancers and in situ carcinomas) and should be able to provide blood samples safely.

What is being tested?

The study tests Bluestar Genomics' non-invasive early detection test for hidden pancreatic cancer in patients newly diagnosed with type II diabetes. If the test indicates potential cancer, an MRI will confirm its presence. The study aims to enroll 10,000 participants.

What are the potential side effects?

Since this trial involves a diagnostic test rather than medication or invasive procedures, side effects are minimal but may include discomfort or bruising from blood draws and anxiety from testing results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had pancreatic cancer.

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I am 50 years old or older.

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I have never had pancreatitis or any type of cysts in my pancreas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had HIV/AIDS, Hepatitis A or E, TB, or any prion disorder like CJD in the last 5 years.

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I have lesions in my pancreas.

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I have been diagnosed with diabetes.

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I have received an organ transplant.

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I have not had immunotherapy in the last year.

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I have not had a blood transfusion in the last month.

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I am currently taking oral steroids regularly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months or until diagnostic resolution

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months or until diagnostic resolution

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months or until diagnostic resolution for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical performance of test: IPMNs sensitivity

Clinical performance of test: Specificity

Clinical performance of test: pancreatic cancer sensitivity

Secondary study objectives

Negative Predictive Value

Positive Predictive Value

Stage Shift

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: EpiDetect ArmExperimental Treatment1 Intervention

Each subject can undergo to up to 3 blood draws; at the time of enrollment (T0), at 6 months (T1) and 12 months (T2) from diabetes diagnosis. After 24 months from diabetes diagnosis, a review of the electronic medical records (EMR) will be performed for all subjects with a "not detected" test result.

Group II: EpiDetect "not detected" MRI ArmExperimental Treatment1 Intervention

A pre-specified number of cases with test results "not detected" will be randomly selected, gender ratio and age matched to subjects with test results "detected" and will undergo MRI imaging at T0 (n=226), at T1 (n=208 ) at T2 (n=208 ) and 24 months (n=208) from diabetes diagnosis.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for pancreatic cancer include surgery, chemotherapy, and radiation therapy. Surgery aims to remove the tumor and is often the best chance for a cure if the cancer is detected early. Chemotherapy uses drugs to kill cancer cells or stop them from growing and dividing, and is often used in combination with surgery or for advanced stages of the disease. Radiation therapy uses high-energy rays to target and kill cancer cells. Early detection, such as through the Bluestar Genomics Early-Detection Pancreatic Cancer Test, is crucial because it can identify cancer at a stage when surgery is more likely to be effective, potentially improving survival rates and outcomes for patients.

Synergistic Analysis of Circulating Tumor Cells Reveals Prognostic Signatures in Pilot Study of Treatment-Naïve Metastatic Pancreatic Cancer Patients.Pancreatic cancer: updates on translational research and future applications.Biomarkers of pancreatic cancer.