RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-29

Study Completion:2024-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04929015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening * Patients with cardiovascular or pulmonary risk factors contributing to high risk for surgical complications, at the discretion of the surgeon * Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator

Inclusion Criteria

Exclusion 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

* 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, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
* Patients with cardiovascular or pulmonary risk factors contributing to high risk for surgical complications, at the discretion of the surgeon
* Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator

Contacts and Locations

Principal Investigator

Henry R Alexander, MD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

RWJBarnabas Health - Cooperman Barnabas, Livingston

Livingston, New Jersey, 07039

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Henry R Alexander, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-29

Study Completion Date2024-11-01

Study Record Updates

Study Start Date2021-04-29

Study Completion Date2024-11-01

Terms related to this study

Additional Relevant MeSH Terms

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