Investigating microRNA for diagnosing and treating pancreatic cancer
The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
This study is testing whether certain tiny molecules in the blood can help doctors diagnose pancreatic cancer earlier and see how well treatments are working for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nuvance Health Academic / other |
| Locations | 1 site (Norwalk, Connecticut) |
| Trial ID | NCT04406831 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of microRNA (miRNA) in pancreatic cancer by collecting serum samples from patients with newly diagnosed pancreatic cancer. Researchers will analyze the miRNA profiles at various time points, including before treatment and monthly during treatment, to identify specific miRNAs that may serve as biomarkers for early diagnosis and treatment response. The study seeks to differentiate pancreatic cancer patients from healthy individuals and correlate miRNA levels with treatment outcomes, potentially leading to the development of a diagnostic test.
Who should consider this trial
Good fit: Ideal candidates include individuals with biopsy-proven adenocarcinoma of the pancreas who have initially inoperable disease.
Not a fit: Patients who have received prior anti-cancer treatments for metastatic pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and personalized treatment strategies for pancreatic cancer patients.
How similar studies have performed: While the role of miRNA in cancer has been explored, this specific approach to pancreatic cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have biopsy proven adenocarcinoma of the pancreas * Have initially inoperable disease, classified as either locally advanced or metastatic disease * Recurrent disease after a Whipple procedure is allowed * Patients who are able to undergo resection after neoadjuvant therapy will continue to be followed after resection * Have radiographically measurable disease * Have an ECOG performance status of 2 or less * Be willing to contribute the required information and specimens * Provide written signed consent to participate Exclusion Criteria: * Having received prior anti-cancer treatments for metastatic pancreatic cancer * Concurrently receiving systemic therapy for another cancer except androgen deprivation therapy for stable/controlled prostate cancer * Presence of other active cancer except for: adequately treated local basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for \>1 year prior to start of trial. Other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for \> 5 years is allowable
Where this trial is running
Norwalk, Connecticut
- Nuvance Health — Norwalk, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Richard Frank, MD — Nuvance Health
- Study coordinator: Pramila Krumholtz, RN
- Email: pramila.krumholtz@nuvancehealth.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.