The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
NCT ID: NCT04406831
Last Updated: 2024-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2015-04-30
2027-04-30
Brief Summary
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Detailed Description
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1. To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline before treatment and monthly throughout treatment.
2. To analyze the miRNA profiles present at each time point.
3. To determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
4. To determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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New Unresectable Pancreatic Cancer
Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease
Blood draw
Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw
Control
Healthy individuals without cancer diagnoses to provide reference microRNA
Blood draw
Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw
Interventions
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Blood draw
Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Nuvance Health
OTHER
Responsible Party
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Richard Frank
Director of Cancer Research
Principal Investigators
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Richard Frank, MD
Role: PRINCIPAL_INVESTIGATOR
Nuvance Health
Locations
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Nuvance Health
Norwalk, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15-10
Identifier Type: -
Identifier Source: org_study_id
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