Trials / Unknown

UnknownNCT04929015

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

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 30 (estimated)

Sponsor: Rutgers, The State University of New Jersey · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

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.

Conditions

Interventions

Type	Name	Description
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
OTHER	Electronic Health Record Review	Medical record reviewed

Timeline

Start date: 2021-04-29
Primary completion: 2024-11-01
Completion: 2024-11-01
First posted: 2021-06-18
Last updated: 2024-03-21

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04929015. Inclusion in this directory is not an endorsement.