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ctDNA-Guided Treatment for Gastrointestinal Cancer

Q: Are new participants being accepted for this research project currently?

The data on clinicaltrials.gov suggests that this study is open for enrollment, having been initially posted in April 2021 and recently revised in November 2022.

Q: What is the primary purpose of this experiment?

The primary objective of this trial, which will be assessed at baseline, pre-surgery, three to four weeks post-surgery and then every 3 months up until two years after cytoreductive surgery (CRS), is to understand the correlation between ctDNA clearance and chemotherapy efficacy. Secondary objectives involve exploring relationships between ctDNA levels with next generation sequence analysis results from original tumor tissue as well as CA125 and CEA levels over the same period.

Q: How many participants are engaging in this medical trial?

Affirmative. Clinicaltrials.gov has recorded that this medical study, which was first uploaded on April 29th 2021, is currently enrolling patients. 30 individuals need to be sourced from two different clinical sites.

N/A

Recruiting

Led By Henry R Alexander, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Patients with histologically confirmed carcinoma of presumed gastrointestinal origin with documented diffuse peritoneal carcinomatosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (crs)

Awards & highlights

Study Summary

This trial is collecting biosamples to create a personalized ctDNA test to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis.

Who is the study for?

Adults with certain gastrointestinal cancers and peritoneal carcinomatosis, who are candidates for surgical treatment. They should have a life expectancy of at least 12 months, be able to perform daily activities with some limitations (ECOG <=2), and consent to regular medical exams, blood draws, and imaging. Pregnant women or those with serious health risks unsuitable for surgery are excluded.Check my eligibility

What is being tested?

The PERICLES Study is collecting blood and tissue samples from patients to develop personalized ctDNA tests that monitor cancer presence over time by detecting abnormal DNA levels in the bloodstream after treatment.See study design

What are the potential side effects?

Since this trial involves biospecimen collection rather than drug intervention, typical side effects associated with medications aren't expected. However, there may be minimal risks related to blood drawing such as bruising or infection at the needle site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer started in the gastrointestinal tract and has spread throughout the abdomen.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (crs)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (crs)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (crs) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Correlation of ctDNA clearance with activity of chemotherapy

Secondary outcome measures

Associations between CA125 levels and ctDNA levels

Associations between CA19.9 levels and ctDNA levels

Associations between CEA levels and ctDNA levels

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (biospecimen collection)Experimental Treatment2 Interventions

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,202 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,491 Total Patients Enrolled

13 Trials studying Peritoneal Carcinomatosis

453 Patients Enrolled for Peritoneal Carcinomatosis

Henry R Alexander, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

Biospecimen Collection - blood and tissue sample collection Clinical Trial Eligibility Overview. Trial Name: NCT04929015 — N/A

Peritoneal Carcinomatosis Research Study Groups: Diagnostic (biospecimen collection)

Peritoneal Carcinomatosis Clinical Trial 2023: Biospecimen Collection - blood and tissue sample collection Highlights & Side Effects. Trial Name: NCT04929015 — N/A

Biospecimen Collection - blood and tissue sample collection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929015 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for this research project currently?

"The data on clinicaltrials.gov suggests that this study is open for enrollment, having been initially posted in April 2021 and recently revised in November 2022."

Answered by AI

What is the primary purpose of this experiment?

"The primary objective of this trial, which will be assessed at baseline, pre-surgery, three to four weeks post-surgery and then every 3 months up until two years after cytoreductive surgery (CRS), is to understand the correlation between ctDNA clearance and chemotherapy efficacy. Secondary objectives involve exploring relationships between ctDNA levels with next generation sequence analysis results from original tumor tissue as well as CA125 and CEA levels over the same period."

Answered by AI

How many participants are engaging in this medical trial?

"Affirmative. Clinicaltrials.gov has recorded that this medical study, which was first uploaded on April 29th 2021, is currently enrolling patients. 30 individuals need to be sourced from two different clinical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Henry Richard Alexander, MD 2021. "Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04929015.

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