Platelet RNA Expression for Ovarian Cancer

(SENTRY Trial)

Overseen By Sophie Eckel, CCRC, MPH, CPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Active malignancy, Recent cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

245 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if changes in platelet RNA (a type of genetic material in blood cells) can aid in the early diagnosis of ovarian cancer. Researchers seek to assess the accuracy of their method by analyzing RNA samples from women with ovarian cancer, ovarian masses, and healthy women. Women recently diagnosed with an ovarian mass or ovarian cancer within the past 8 weeks may be suitable for this study. Participants will need to provide a blood sample for analysis. As a Phase 2 trial, this research measures the method's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking diagnostic advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on excluding participants with recent cancer treatments or certain health conditions.

What prior data suggests that this analytical approach is safe for diagnosing ovarian cancer?

Research has shown that platelet RNA can help detect ovarian cancer. Studies have found that analyzing RNA in platelets, small parts of blood cells that aid in clotting, can accurately identify ovarian cancer.

No evidence indicates that collecting and studying platelet RNA is unsafe for participants, as it only requires a blood draw—a common and generally safe procedure for most people.

In summary, research suggests that using platelet RNA to diagnose ovarian cancer is a promising and safe method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to diagnosing ovarian cancer early by examining changes in platelet RNA. Unlike traditional diagnostic methods that rely on imaging or invasive procedures, this technique could offer a non-invasive, potentially quicker way to detect the disease. By identifying ovarian cancer at an earlier stage, this method might improve treatment outcomes and survival rates, offering hope for better management of this challenging condition.

What evidence suggests that this analytical approach is effective for diagnosing ovarian cancer?

Research has shown that examining RNA in platelets offers a promising method for early detection of ovarian cancer. This trial will study platelet RNA expression in various groups, including women recently diagnosed with an ovarian mass, women recently diagnosed with ovarian cancer, and control women without ovarian cancer. Studies have found that changes in platelet RNA can accurately identify ovarian cancer, demonstrating high sensitivity (correctly identifying those with the disease) and specificity (correctly ruling out those without the disease). Platelets, tiny blood cells that aid in clotting, undergo RNA changes when diseases like cancer are present. These changes can help detect ovarian cancer sooner than many current methods. Early findings suggest this approach could enhance early diagnosis, which is crucial because early detection significantly increases survival rates. ^{2 4 6 7 8}

Who Is on the Research Team?

Theresa Werner, MD

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a woman recently diagnosed with ovarian cancer.

I am a woman aged 21 or older.

I was diagnosed with ovarian cancer in the last 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants provide platelet RNA samples from whole blood for analysis

1 day

1 visit (in-person)

Validation Analysis

Validation analyses are performed to test the hypothesis on platelet RNA expression changes

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after sample collection and analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Platelet RNA Expression

How Is the Trial Designed?

Group I: Women with a Recent Diagnosis of Ovarian Mass (n=125) Experimental Treatment 1 Intervention

Group II: Women with a Recent Diagnosis of Ovarian Cancer (n=90) Experimental Treatment 1 Intervention

Group III: Control Women without Ovarian Cancer (n=30) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39715465/

Impact of clinical factors on accuracy of ovarian cancer ... Platelet RNA sequencing, which reflects host response to disease, shows promise for earlier OC detection.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589004225005413

Catalyzing early ovarian cancer detection: Platelet RNA- ... However, once the cancer metastasizes, the 5-year survival rate diminishes by less than 30%. Unfortunately, due to the absence of disease- ...

3. mdpi.com mdpi.com/2072-6694/17/7/1251

Innovative qPCR Algorithm Using Platelet-Derived RNA for ... This study aims to develop a cost-effective and accessible diagnostic method using qPCR-based platelet RNA profiling to detect ovarian cancer earlier.

4. academic.oup.com academic.oup.com/proteincell/article/14/8/579/6821244

Platelet RNA enables accurate detection of ovarian cancer Altered counts, functions, and highly dynamic RNA repertoire of platelets provide a substantial basis for utilizing their RNA profiles to detect ovarian cancer.

5. cell.com cell.com/iscience/pdf/S2589-0042(25)00541-3.pdf

iScience - Catalyzing early ovarian cancer detection 1 However, once the cancer metastasizes, the 5-year survival rate diminishes by less than 30%. 2 Unfortunately, due to the absence of disease- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12148375/

Catalyzing early ovarian cancer detection: Platelet RNA ... It is known that RNA from platelets can accurately detect ovarian cancer. However, achieving accurate detection with high specificity is vital ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842824002087

Unlocking the intricacies: Exploring the complex interplay ... This review aims to thoroughly dissect the interactions between platelets and ovarian cancer cells, emphasizing their combined role in tumor progression and ...

8. ashpublications.org ashpublications.org/blood/article/137/23/3181/475896/Platelets-and-tumor-associated-RNA-transfer

Platelets and tumor-associated RNA transfer - ASH Publications Cancer cells can directly and/or indirectly influence platelet RNA content, resulting in tumor-mediated “education” of platelets.