Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)

This clinical trial collects biospecimen samples to create a personalized ctDNA test to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis. Deoxyribonucleic acid, or DNA, is the material that carries all the information about how a living thing will work and function. Everyone is born with the same DNA in all our cells throughout our body. Sometimes, some of the cells in the body develop abnormalities in the DNA that cause those cells to grow abnormally and uncontrollably. Cancer occurs when there is abnormal and uncontrolled growth of cells. The DNA in cancer cells is therefore different from the DNA someone is born with. The Signatera ctDNA assay is a laboratory test that takes tumor (cancer) tissue and evaluates it for unique tumor DNA. This evaluation is used to create a report (otherwise known as an assay) personalized to each person's cancer. The personalized assay creates a personalized blood test to detect the level of abnormal DNA from the cancer that may be circulating in the body. Once this personalized blood assay is designed, it may be used to monitor a person's blood for the presence of ctDNA, which will indicate the presence or absence of cancer over time, even after treatment.

Study Overview

• Status: Suspended
• Conditions: Peritoneal Carcinomatosis; Digestive System Neoplasm; Liver and Intrahepatic Bile Duct Carcinoma; Appendix Carcinoma by AJCC V8 Stage; Colorectal Carcinoma by AJCC V8 Stage; Esophageal Carcinoma by AJCC V8 Stage; Gastric Carcinoma by AJCC V8 Stage
• Intervention / Treatment: Other: Electronic Health Record Review; Procedure: Biospecimen Collection - blood and tissue sample collection

Detailed Description

This study is an exploratory analysis of the utility of ctDNA as a sensitive biomarker in patients with Peritoneal Carcinomatosis treated with chemotherapy, CRS and/or hyperthermic intraperitoneal chemotherapy (HIPEC).

OBJECTIVES:

I. To measure changes in circulating tumor deoxyribonucleic acid (ctDNA) in patients with peritoneal carcinomatosis (PC) from gastrointestinal (GI) cancers who are candidates for cytoreductive surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC).

II. To determine the percentage of patients on protocol with undetectable ctDNA (clearance rate) after complete CRS.

III. To identify any associations between clinical staging of CRS and measurable ctDNA.

IV. To assess changes in ctDNA levels in response to chemotherapy in patients with PC.

V. To guide treatment based on ctDNA response.

OUTLINE:

Patients may receive induction chemotherapy at the discretion of the treating physician for up to 6 months. Patients undergo blood sample collection for ctDNA analysis at baseline, post chemotherapy/pre-surgery, 3-4 weeks post CRS/HIPEC, then every 3 months over 2 years. Patients also undergo tissue collection before or during surgery and their medical records are reviewed.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • RWJBarnabas Health - Cooperman Barnabas, Livingston
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (biospecimen collection); Patients will receive standard treatment with surgery, HIPEC, and chemotherapy as appropriate to the patient situation, extent of disease and multi-disciplinary evaluation. Patients undergo blood sample collection for ctDNA analysis at baseline, pre-surgery, post-surgery and every 3 months up to 2 years. Patients undergo tissue collection before or during surgery and their medical records are reviewed.

Other: Electronic Health Record Review; Medical record reviewed; Procedure: Biospecimen Collection - blood and tissue sample collection; The original tissue sample from each patient will be obtained at time of surgery or prior to surgery. Plasma for ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance rate of circulating tumor deoxyribonucleic acid (ctDNA) with cytoreductive surgery (CRS)	Will compare results with clinical staging of CRS (surgical staging, surgical outcomes, Peritoneal Carcinoma Index [PCI] and cytoreduction [CC] score). ctDNA clearance rate defined as the % of patients on our protocol with undetectable ctDNA. Will associate ctDNA changes with clinical response by Response Evaluation Criteria in Solid Tumors and surgical staging, surgical outcomes, PCI and CC score using standard T-testing, log-rank analysis or similar non-parametric testing.	Baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Correlation of ctDNA clearance with activity of chemotherapy	Will correlate ctDNA clearance with activity of chemotherapy in this disease pre-op and post-op	Baseline, pre-surgery, 3-4 weekd post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positivity rate of ctDNA in patients with peritoneal carcinomatosis	ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years	Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
ctDNA and its association with results of next generation sequence (NSG) analysis from original tumor tissue.	ctDNA will be obtained at baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years. ctDNA from blood samples will be compared with the results of NSG analysis from original tumor tissue	Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Associations between CEA levels and ctDNA levels	ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years	Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)
Associations between CA19.9 levels and ctDNA levels	ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years	Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)
Associations between CA125 levels and ctDNA levels	ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years	Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Henry R Alexander, MD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Peritoneal Diseases; Abdominal Neoplasms; Carcinoma, Hepatocellular; Peritoneal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: Pro2021000017; P30CA072720 (U.S. NIH Grant/Contract); 072013 (Other Identifier: Rutgers Cancer Institute of New Jersey); NCI-2021-02123 (Registry Identifier: NCI CTRP registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No