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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNuvance Health

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Individuals with new diagnoses of unresectable pancreatic cancer, or recurrent pancreatic cancer following a Whipple procedure

Trial design

Design model

Ecologic or community

Time perspective

Prospective

Treatments tested in this trial

  • Blood draw

    Procedure/Surgery

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: New Unresectable Pancreatic Cancer1 intervention
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

Analysis of miRNA profile

Analyze the miRNA profiles present at each time point.

Time frame
Through study completion, up to 5 years

Secondary outcomes

1

PCR miRNA validation

Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.

Time frame
Through study completion, up to 5 years
2

miRNA PCR expression

Determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.

Time frame
Through study completion, up to 5 years

Other outcomes

Sponsors and contacts

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