RecruitingNot ApplicableNCT04929015

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


Sponsor

Rutgers, The State University of New Jersey

Enrollment

30 participants

Start Date

Apr 29, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a blood test that detects tumor DNA (called liquid biopsy or ctDNA) to guide treatment decisions for people with gastrointestinal cancers that have spread to the lining of the abdomen (peritoneal carcinomatosis). **You may be eligible if...** - You have been diagnosed with a cancer originating from the stomach, esophagus, colon, rectum, appendix, bile ducts, liver, or the abdominal lining itself - The cancer has spread to the lining of your abdomen - Your doctors believe surgery to remove the cancer may be possible - You are 18 or older and in generally good physical condition - Your life expectancy is at least 12 months **You may NOT be eligible if...** - Your cancer has spread too widely for surgery to be considered - You are not well enough to undergo surgery - You are unable or unwilling to attend follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen 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

OTHERElectronic Health Record Review

Medical record reviewed


Locations(2)

RWJBarnabas Health - Cooperman Barnabas, Livingston

Livingston, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

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NCT04929015


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