RecruitingNCT04406831

The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer


Sponsor

Nuvance Health

Enrollment

200 participants

Start Date

Apr 1, 2015

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria3

  • 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

Interventions

PROCEDUREBlood draw

Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw


Locations(1)

Nuvance Health

Norwalk, Connecticut, United States

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NCT04406831


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