Platelet RNA-based Assay for Lung Cancer
(SPARC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for diagnosing lung cancer using a blood test that examines changes in platelet RNA, a type of genetic material. This platelet RNA-based assay aims to determine if the test can distinguish between cancerous and non-cancerous lung nodules. The trial seeks individuals newly diagnosed with lung cancer or those with lung nodules requiring further testing. Participants must provide a blood sample for the study. As a Phase 2 trial, the research focuses on assessing the test's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to early diagnostic advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are currently receiving systemic therapy or radiation therapy for lung cancer, you would not be eligible to participate.
What prior data suggests that this platelet RNA-based assay is safe for diagnosing lung cancer?
Research has shown that the platelet RNA-based test safely detects lung cancer. Earlier studies used this test to identify up to 18 different types of cancer with high accuracy. Importantly, participants in these studies generally tolerated the test well, experiencing few significant side effects.
The test requires only a small blood sample, a routine procedure with minimal risk. It has already shown promise in detecting lung cancer early and tracking the disease's progress. This suggests it is both a safe and effective tool for diagnosing cancer.12345Why are researchers excited about this trial?
Researchers are excited about the Platelet RNA-based assay for lung cancer because it offers a new way to detect and monitor the disease. Unlike traditional imaging and biopsy methods, this assay analyzes RNA from platelets in the blood, which is less invasive and can provide real-time insights into the cancer's progression. This approach could lead to earlier detection and more personalized treatment plans, improving outcomes for patients with lung cancer and lung nodules.
What evidence suggests that the platelet RNA-based assay is effective for diagnosing lung cancer?
Research has shown that tumor-educated platelets (TEPs), which exhibit altered RNA patterns due to tumor interaction, can aid in diagnosing lung cancer. This trial will use a Platelet RNA-based assay to investigate its diagnostic potential. One study found that TEPs could distinguish between lung adenocarcinoma and squamous cell carcinoma, achieving accuracy scores of 0.791 and 0.826, respectively. Another study demonstrated that analyzing platelet RNA enabled a computer program to detect cancer in 64% of cases, with 99% accuracy in asymptomatic individuals. This indicates that examining RNA in platelets could be a promising method for identifying lung cancer and differentiating between benign and malignant lung nodules.26789
Who Is on the Research Team?
Shiven Patel, MD/MBA
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
This trial is for adults aged 21 or older who have either been newly diagnosed with any type of lung cancer or have a lung nodule found on imaging and are scheduled for further testing or treatment. People can't join if they recently had major surgery, certain cancers, serious heart, liver, or kidney problems, recent blood transfusions, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sample Collection and Analysis
Participants with newly diagnosed lung cancer have platelet RNA samples collected from whole blood for validation analyses
Follow-up
Participants are monitored for assay performance and validation completion
What Are the Treatments Tested in This Trial?
Interventions
- Platelet RNA-based assay
Trial Overview
The study is testing a new blood test that looks at RNA in platelets using AI to help diagnose lung cancer and tell the difference between harmless and cancerous lung nodules. Blood samples will be collected from participants to validate how well this test works.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Cohort 3 will enroll 30 participants without Lunch Cancer or lunch Nodules. Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
Cohort 1 will enroll 120 participants with Lung Nodules (72 patients with Benign Nodules and 48 participants with Malignant Nodules). Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
Cohort 1 will enroll 90 participants with Lung Cancer (30 patients with Stage I/II and 60 participants with Stage III/IV). Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
United States Department of Defense
Collaborator
Citations
Tumor-educated platelet RNA as a diagnostic biomarker for ...
The aim of this study was to integrate highly specific tumor-educated platelet (TEP)-derived biomarkers to optimize preoperative evaluation.
Tumor-educated platelet blood tests for Non-Small Cell ...
Tumor-educated platelets (TEPs) have emerged as a promising liquid biopsy biosource for the detection of various cancer types.
Tumor Educated Platelets as a Biomarker for Diagnosis ... - PMC
The study has found that SNORD55 RNA is effective in diagnosing Lung Adenocarcinoma and SCC, with an AUC of 0.791 and 0.826, respectively. The study also ...
Clinical utility and diagnostic value of tumor-educated ...
The review addresses the knowledge gap concerning the diagnostic value and clinical utility of tumor-educated platelets (TEPs) in adult patients with lung ...
5.
research.vu.nl
research.vu.nl/en/publications/platelet-rna-biomarker-a-new-avenue-in-lung-disease-detection/Platelet RNA Biomarker: A New Avenue in Lung Disease ...
The algorithm achieved 99% specificity in asymptomatic individuals, detecting cancer in 64% of cases. Additionally, thromboSeq accurately ...
Tumor-educated platelet blood tests for Non-Small Cell Lung ...
Recently, we developed a TEP RNA-based blood test that enables the detection of 18 different cancer types with 99% of specificity, showing ...
Comprehensive circRNA profiling of platelets and ...
In the present study, by sequencing paired platelets and plasma exosomes from LUAD patients and controls, we identified compartment-specific circRNA signatures, ...
Combinatorial Blood Platelets-Derived circRNA and mRNA ...
Here, we investigated the synergistic contributions of circRNA and mRNA signatures derived from blood platelets as biomarkers for lung cancer detection.
Tumor-educated platelet RNA as a diagnostic biomarker for ...
TEPs can be used for the early diagnosis of lung cancer can not only enhance the sensitivity and specificity of detection and may also serve as ...
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