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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406831
• Other study ID #: 15-10
• Status: Recruiting
• Start date: April 2015
• Est. completion date: April 2027

Study information

• Verified date: March 2024
• Source: Nuvance Health
• Contact: Pramila Krumholtz, RN
• Email: pramila.krumholtz[@]nuvancehealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer Stage III
• Pancreatic Cancer Stage IV
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Nuvance Health	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Nuvance Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of miRNA profile	Analyze the miRNA profiles present at each time point.	Through study completion, up to 5 years
Secondary	PCR miRNA validation	Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.	Through study completion, up to 5 years
Secondary	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.	Through study completion, up to 5 years