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Microbiome Study for Appendiceal Cancer

N/A

Recruiting

Led By Armando Sardi, MD

Research Sponsored by Mercy Medical Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group performance status score of ≤2/Karnofsky performance status (KPS) ≥70%

Candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC)

Must not have

<18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the difference in gut bacteria in people with appendix cancer before and after surgery.

Who is the study for?

This trial is for adults aged 18-80 with appendiceal cancer that has spread to the peritoneum, who are fit enough for major surgery (CRS/HIPEC) based on performance scores. Pregnant women and those with severe medical issues not related to their cancer cannot participate.

What is being tested?

The study is collecting fecal samples from patients before and after they undergo cytoreductive surgery combined with heated chemotherapy (CRS/HIPEC) to analyze changes in the gastrointestinal microbiome associated with appendiceal cancer.

What are the potential side effects?

There may be minimal side effects related to bio-specimen collection such as discomfort or minor bleeding. The questionnaire poses no physical risk but may include questions that cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly self-sufficient and can carry out daily activities.

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I am a candidate for surgery to remove a tumor and heated chemotherapy in the abdomen.

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I am between 18 and 80 years old.

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My cancer started in the appendix and has spread to the lining of my abdomen.

Exclusion Criteria

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

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort

Secondary study objectives

Compare the gut microbiome of appendiceal tumors by histopathology

Other study objectives

Identify alterations in the gut microbiome post-CRS/HIPEC

Identify potential biomarkers associated with appendiceal tumors

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: Microbiome cohortExperimental Treatment2 Interventions

1. Pre-operative (baseline) bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires. 2. Six to twelve weeks following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC), post-operative bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires 3. Six to twelve months following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC), post-operative bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mercy Medical CenterLead Sponsor

20 Previous Clinical Trials

4,198 Total Patients Enrolled

1 Trials studying Appendiceal Neoplasms

80 Patients Enrolled for Appendiceal Neoplasms

University of California, San DiegoOTHER

1,180 Previous Clinical Trials

1,575,023 Total Patients Enrolled

1 Trials studying Appendiceal Neoplasms

Armando Sardi, MD4.615 ReviewsPrincipal Investigator - Mercy Medical Center

Mercy Medical Center

1 Previous Clinical Trials

62 Total Patients Enrolled

5Patient Review

This doctor was outstanding in every way. They made me feel cared for and comforted me with their great bedside manner. They were also extremely knowledgeable, friendly, and funny. I couldn't have asked for more.