SuspendedNot Applicable

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

Stopped: Pending Protocol amendment

United States30 participantsStarted 2021-04-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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, cl…

What they're measuring

Clearance rate of circulating tumor deoxyribonucleic acid (ctDNA) with cytoreductive surgery (CRS)

Timeframe: 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

Timeframe: Baseline, pre-surgery, 3-4 weekd post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)

Trial details

NCT IDNCT04929015

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Appendix Carcinoma by AJCC V8 Stage trials