Clinical trial NCT04406831: The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
Official title: The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer Stage III
Pancreatic Cancer Stage IV
Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasms
Keywords: Pancreas
Cancer
Biomarker
Lead sponsor: Nuvance Health
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with new diagnoses of unresectable pancreatic cancer, or recurrent pancreatic cancer following a Whipple procedure

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.

Detailed description: Specific aims of the study include:

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.

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

Primary outcomes:
measure: Analysis of miRNA profile
timeFrame: Through study completion, up to 5 years
Secondary outcomes:
measure: PCR miRNA validation
timeFrame: Through study completion, up to 5 years
measure: miRNA PCR expression
timeFrame: Through study completion, up to 5 years
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Nuvance Health
state: Connecticut
Study officials:
affiliation: Nuvance Health
name: Richard Frank, MD
role: PRINCIPAL_INVESTIGATOR
References: