NCT04406831 The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
| NCT ID | NCT04406831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nuvance Health |
| Condition | Pancreatic Cancer Stage III |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2015-04 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2015-04 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aberrant miRNA production has been linked to a wide range of human cancers and shown to play important roles in their genesis and growth. These miRNA can be detected in the blood and tumors of patients with cancer. The investigators hypothesize that the detection of certain miRNAs present in the blood/serum of patients with pancreatic cancer may be important to the early diagnosis of the disease. Furthermore, the investigators hypothesize that miRNA detection in PC patients will yield prognostic information and help predict the response to treatment.
Eligibility 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
Contact & Investigator
Pramila Krumholtz, RN
✉ pramila.krumholtz@nuvancehealth.orgRichard Frank, MD
PRINCIPAL INVESTIGATOR
Nuvance Health
Frequently Asked Questions
Who can join the NCT04406831 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer Stage III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04406831 currently recruiting?
Yes, NCT04406831 is actively recruiting participants. Contact the research team at pramila.krumholtz@nuvancehealth.org for enrollment information.
Where is the NCT04406831 trial being conducted?
This trial is being conducted at Norwalk, United States.
Who is sponsoring the NCT04406831 clinical trial?
NCT04406831 is sponsored by Nuvance Health. The principal investigator is Richard Frank, MD at Nuvance Health. The trial plans to enroll 200 participants.
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