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ctDNA-Guided Treatment for Gastrointestinal Cancer

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

Must not have

Patients who cannot undergo a therapeutic surgical cytoreduction

Patients without a confirmed pathologic diagnosis of carcinoma

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have surgery to reduce my cancer.

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I do not have a confirmed diagnosis of cancer.

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I have received a bone marrow or organ transplant.

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I have not had any serious health issues in the last 6 months.

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I have another cancer that is not under control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Correlation of ctDNA clearance with activity of chemotherapy

Secondary study objectives

Associations between CA125 levels and ctDNA levels

Associations between CA19.9 levels and ctDNA levels

Associations between CEA levels and ctDNA levels

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met