Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Carcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Carcinoma, Ductal

Digestive System Neoplasms

Colorectal Neoplasms

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Abdominal Neoplasms

Peritoneal Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Diseases

Esophageal Cancer

Bile Duct Cancer

Stomach Cancer

Intrahepatic Cholangiocarcinoma

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.

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

Biospecimen Collection - blood and tissue sample collection

Electronic Health Record Review

Henry Richard Alexander, MD

Henry R Alexander, MD

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.

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.

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

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.

Will correlate ctDNA clearance with activity of chemotherapy in this disease pre-op and post-op

ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years

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

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Chief Surgical Officer, Rutgers Cancer Institute of New Jersey

Spots Global Cancer Trial Database for colorectal carcinoma by ajcc v8 stage