Personalized ctDNA testing for gastrointestinal cancer treatment
Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)
This study is testing a new blood test that looks at tumor DNA to help doctors personalize treatment for patients with advanced gastrointestinal cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Livingston, New Jersey and 1 other locations) |
| Trial ID | NCT04929015 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on developing a personalized blood test using circulating tumor DNA (ctDNA) to guide treatment for patients with gastrointestinal cancers that have spread to the peritoneum. It involves collecting blood and tissue samples from patients undergoing chemotherapy and cytoreductive surgery, with the aim of measuring changes in ctDNA levels throughout their treatment. The study will assess the effectiveness of ctDNA as a biomarker for monitoring disease progression and treatment response, ultimately aiming to improve patient outcomes through tailored therapies.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed gastrointestinal cancers exhibiting peritoneal carcinomatosis who are eligible for surgical intervention.
Not a fit: Patients with non-gastrointestinal cancers or those not candidates for cytoreductive surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment strategies for patients with advanced gastrointestinal cancers.
How similar studies have performed: Other studies have shown promise in using ctDNA as a biomarker in cancer treatment, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically confirmed carcinoma of presumed gastrointestinal origin (gastric, esophageal, colorectal, appendiceal, hepatobiliary or peritoneal carcinomatosis of apparent GI primary) with documented diffuse peritoneal carcinomatosis, either by conventional imaging studies, positive ascitic fluid analysis, or surgical staging * Measurable or evaluable disease by cross-sectional imaging studies * Patients must be candidates for possible surgical cytoreduction (with or without HIPEC) as determined by a study surgical oncologist * Age \>= 18 years * Estimated life expectancy of at least 12 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Patients must sign informed consent * Be willing to present for medical exams, blood draws and imaging as scheduled in protocol * Be able to donate two 10 mL tubes of blood every 3 months * Women of childbearing potential will undergo routine screening evaluation for pregnancy prior to enrollment and be managed per standard of care Exclusion Criteria: * Patients without a confirmed pathologic diagnosis of carcinoma * Second uncontrolled primary malignancy * Patients who are pregnant * Patients who cannot undergo a therapeutic surgical cytoreduction * Bone marrow transplant or other organ transplant recipient * Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening * Patients with cardiovascular or pulmonary risk factors contributing to high risk for surgical complications, at the discretion of the surgeon * Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
Where this trial is running
Livingston, New Jersey and 1 other locations
- RWJBarnabas Health - Cooperman Barnabas, Livingston — Livingston, New Jersey, United States (Recruiting)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Henry R Alexander, MD — Rutgers Cancer Institute of New Jersey
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.