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

Peritoneal Carcinomatosis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Neoplasms
• Digestive System Neoplasm
• Digestive System Neoplasms
• Esophageal Neoplasms
• Gastrointestinal Neoplasms
• Liver and Intrahepatic Bile Duct Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms
• Stomach Neoplasms

• NCT number: NCT04929015
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2021
• Completion date: November 1, 2024