MedTrace Logo

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

NCT04929015 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Appendix Carcinoma by AJCC V8 Stage
  • Colorectal Carcinoma by AJCC V8 Stage
  • Digestive System Neoplasm
  • Esophageal Carcinoma by AJCC V8 Stage
  • Gastric Carcinoma by AJCC V8 Stage
  • Liver and Intrahepatic Bile Duct Carcinoma
  • Peritoneal Carcinomatosis

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Henry R Alexander, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2027-06-30
Completion
2027-09-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04929015 on ClinicalTrials.gov