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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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

Secondary outcome measures

Compare the gut microbiome of appendiceal tumors by histopathology

Other outcome measures

Identify alterations in the gut microbiome post-CRS/HIPEC

Identify potential biomarkers associated with appendiceal tumors

Trial Design

1Treatment groups

Experimental Treatment

Group I: Microbiome cohortExperimental Treatment2 Interventions

Pre-operative (baseline) bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires. 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 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER

1,121 Previous Clinical Trials

1,521,401 Total Patients Enrolled

1 Trials studying Appendiceal Neoplasms

21 Patients Enrolled for Appendiceal Neoplasms

Mercy Medical CenterLead Sponsor

20 Previous Clinical Trials

4,198 Total Patients Enrolled

1 Trials studying Appendiceal Neoplasms

80 Patients Enrolled for 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.

Media Library

Microbiome cohort Clinical Trial Eligibility Overview. Trial Name: NCT02599116 — N/A

Appendiceal Neoplasms Research Study Groups: Microbiome cohort

Appendiceal Neoplasms Clinical Trial 2023: Microbiome cohort Highlights & Side Effects. Trial Name: NCT02599116 — N/A

Microbiome cohort 2023 Treatment Timeline for Medical Study. Trial Name: NCT02599116 — N/A

Frequently Asked Questions

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

Are there any opportunities for new participants to join this trial?

"This clinical trial is still in the process of participant recruitment, with the initial posting occurring on December 1st 2015 and a recent update being made on September 15th 2021."

Answered by AI

Am I eligible to partake in the investigation?

"A total of 24 participants between the ages 18 and 80 are required for this study, who have been diagnosed with appendiceal cancer. Participants must also meet additional criteria such as an Eastern Cooperative Oncology Group performance status score ≤2/Karnofsky performance status (KPS) ≥70%."

Answered by AI

Does this trial accommodate geriatric participants?

"This research is seeking participants aged 18 or above, but below 80 years old."

Answered by AI

How many participants are permitted to join this clinical trial?

"Affirmative. According to information available on clinicaltrials.gov, this medical trial is actively looking for participants; it was first posted in December 2015 and last updated in September 2021 with the goal of recruiting 24 patients at a single study location."

Answered by AI

Recent research and studies

Orphanet Journal of Rare DiseasesJournal

A Core Microbiome Associated with the Peritoneal Tumors of Pseudomyxoma Peritonei

Gilbreath, Jeremy J, Cristina Semino-Mora, Christopher J Friedline, Hui Liu, Kip L Bodi, Thomas J McAvoy, Jennifer Francis, et al.. 2013. “A Core Microbiome Associated with the Peritoneal Tumors of Pseudomyxoma Peritonei”. Orphanet Journal of Rare Diseases. Springer Science and Business Media LLC. doi:10.1186/1750-1172-8-105.

clinicaltrials.govStudy

Gastrointestinal Microbiome Study of Appendiceal Cancer

Armando Sardi 2015. "Gastrointestinal Microbiome Study of Appendiceal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02599116.

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