Miami, FLNCT07096362Now EnrollingIRB Ready

Metastatic Pancreatic Ductal Adenocarcinoma Clinical Trial in Miami, FL

Access cutting-edge metastatic pancreatic ductal adenocarcinoma treatment through this clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by University of Miami

Quick Self-Assessment

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Expert Care in Miami

Access metastatic pancreatic ductal adenocarcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metastatic pancreatic ductal adenocarcinoma treatment provided free

Apply for This Miami Location

Check if you qualify for this metastatic pancreatic ductal adenocarcinoma clinical trial in Miami, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Metastatic Pancreatic Ductal Adenocarcinoma Study in Miami

The purpose of this study is to understand whether a blood-based test called circulating tumor DNA (ctDNA) can detect whether participants are having a desired tumor shrinkage or an undesired lack of tumor shrinkage, and to study whether these levels of ctDNA can be used to make treatment decisions faster than the current standard approach, which is to wait 8 weeks after starting chemotherapy to obtain participant first imaging scans since starting chemotherapy.

Sponsor: University of Miami

Who Can Participate

Inclusion Criteria

Histologically confirmed, metastatic pancreatic adenocarcinoma. Patients with adenosquamous carcinoma and mixed adenocarcinoma/neuroendocrine carcinoma (MANEC) of the pancreas are eligible, but pure neuroendocrine neoplasms are excluded.
Treatment-naïve patients diagnosed with metastatic pancreatic adenocarcinoma.
Must have a detectable circulating tumor deoxyribonucleic acid (DNA) at cycle 1 day 1.
Patients must have a detectable circulating tumor deoxyribonucleic acid (ctDNA) quantity on Northstar Response assay at baseline.
At least one tumor measurable by Computed Tomography (CT) scan or Positron Emission Tomography-Computed Tomography (PET/CT) scan. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or \>10 mm with spiral CT scan.
Adult male and female participants (≥ 18 years of age).
Male or non-pregnant and non-lactating female. Men and women with intact reproductive potential must agree to use contraception.
Adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:
Absolute neutrophil count (ANC) ≥ 1.0 × 109 cells/L.
Platelet count ≥ 100,000 cells/mm3 (100 × 109 cells/L). Supportive platelet transfusions are acceptable.
Hemoglobin (Hgb) ≥ 9 g/dL. Supportive packed red blood cell transfusions are acceptable.
Adequate blood chemistry levels at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:
Aspartate aminotransferase (AST) - serum glutamic-oxaloacetic transaminase (SGOT); alanine transaminase (ALT) - serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 × upper limit of normal (ULN) range, unless liver metastases are present, then ≤ 5 × ULN is allowed.
Total bilirubin ≤ 1.5 × Upper Limit of Normal.
Estimated creatinine clearance of \> 60 mL/min (per Cockcroft-Gault formula).
Albumin ≥ 3.0 g/dL.
Eastern Cooperative Oncology Group (ECOG) performance status from 0 to ≤ 1.
Must be a modified Folfirinox chemotherapy candidate.
For participants not qualified or able to give legal consent, consent must be obtained from their legally authorized representative (LAR).

Exclusion Criteria

Patients with pure neuroendocrine neoplasms of the pancreas.
Brain metastases.
Uncontrolled ascites.
Increase of ECOG to \> 1 between screening and enrollment.
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
History of untreated or uncontrolled HIV and/or Hepatitis B or C infection.
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
History of myocardial infarction, angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within six months prior to study entry
Documented cardiomyopathy
Grade 2 or greater sensory peripheral neuropathy.
History of chronic diarrhea.
Pregnant or nursing.
Concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or integrity of the study data.
Concurrently enrolled in any other interventional clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer.
Patient is unwilling or unable to comply with study procedures.
Patients with impaired decision-making capacity.
No other medical condition or reason that, in the opinion of the investigator, would preclude study participation.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT07096362) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Pancreatic Ductal Adenocarcinoma Treatment Options in Miami, FL

If you're searching for metastatic pancreatic ductal adenocarcinoma treatment options in Miami, FL, this clinical trial (NCT07096362) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic pancreatic ductal adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic pancreatic ductal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

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