Pseudomyxoma PeritoneiNCT02599116
Gastrointestinal Microbiome Study of Appendiceal Cancer
A study testing Bio-specimen collection and Questionnaire in people with Pseudomyxoma Peritonei and Appendiceal Neoplasm, run by Mercy Medical Center at 1 site in United States.
Trial summary
This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pseudomyxoma Peritonei, Appendiceal Neoplasm, Cancer, Appendiceal
- What is being tested?
- Bio-specimen collection and Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of appendiceal cancer with peritoneal spread
- Candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC)
- ≥18 and ≤ 80 years of age
- Eastern Cooperative Oncology Group performance status score of ≤2/Karnofsky performance status (KPS) ≥70%
- Signed Institutional Review Board approved informed consent
Who cannot join
- <18 years of age
- Pregnant women
- Concurrent severe medical problems unrelated to malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mercy Medical Center
Baltimore, Maryland, 21202
About this study
Official title: A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread
This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively.
Read the detailed description
Analysis of the human microbiome is an attempt to define how changes in the human microbiome are associated with health or disease.
Eligible participants scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) for appendiceal cancer will provide fecal samples pre- and post-operatively. Investigators will analyze potential changes in the gastrointestinal microbiome and make comparisons to an age-matched healthy sample.
- Being tested
- Bio-specimen collection, Questionnaire
- Keywords
- cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, microbiome
- Medical subject headings
- Pseudomyxoma Peritonei, Appendiceal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-specimen collectionOther
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
QuestionnaireOther
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint
| Study group | Role | What they receive |
|---|---|---|
| Microbiome cohort | Other | 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 Receives: Other: Bio-specimen collection; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort
Appendiceal cohort to healthy age-matched cohort
Measured: 36 months
Secondary outcomes (1)
Compare the gut microbiome of appendiceal tumors by histopathology
Low-grade and high-grade tumors
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pseudomyxoma PeritoneiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Armando Sardi, Mercy Medical Center
- Investigators
- Armando Sardi, MD, Principal investigator, Mercy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599116
- Sponsor's protocol ID
- MMC 2015-53
- Status last verified
- Mar 2023
- First submitted
- 4 Nov 2015
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gilbreath JJ, Semino-Mora C, Friedline CJ, Liu H, Bodi KL, McAvoy TJ, Francis J, Nieroda C, Sardi A, Dubois A, Lazinski DW, Camilli A, Testerman TL, Merrell DS. A core microbiome associated with the peritoneal tumors of pseudomyxoma peritonei. Orphanet J Rare Dis. 2013 Jul 12;8:105. doi: 10.1186/1750-1172-8-105.
PubMed 23844722
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread
- ClinicalTrials.gov ID
- NCT02599116
- Acronym / sponsor ID
- MMC 2015-53
- Keywords
- cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mercy Medical CenterUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- Dec 2015
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively.
Detailed description
Analysis of the human microbiome is an attempt to define how changes in the human microbiome are associated with health or disease.
Eligible participants scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) for appendiceal cancer will provide fecal samples pre- and post-operatively. Investigators will analyze potential changes in the gastrointestinal microbiome and make comparisons to an age-matched healthy sample.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microbiome cohort | Other | Other: Bio-specimen collection, Other: Questionnaire1. 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of appendiceal cancer with peritoneal spread
- Candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC)
- ≥18 and ≤ 80 years of age
- Eastern Cooperative Oncology Group performance status score of ≤2/Karnofsky performance status (KPS) ≥70%
- Signed Institutional Review Board approved informed consent
Key exclusion criteria (3 listed)
- <18 years of age
- Pregnant women
- Concurrent severe medical problems unrelated to malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-specimen collectionCollection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections | Other | Microbiome cohort |
| QuestionnaireCompletion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint | Other | Microbiome cohort |
Primary outcome
Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort
Time frame: 36 months
Appendiceal cohort to healthy age-matched cohort
1 secondary outcome
Compare the gut microbiome of appendiceal tumors by histopathology
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Results publication: PubMed 23844722Gilbreath JJ, Semino-Mora C, Friedline CJ, Liu H, Bodi KL, McAvoy TJ, Francis J, Nieroda C, Sardi A, Dubois A, Lazinski DW, Camilli A, Testerman TL, Merrell DS. A core microbiome associated with the peritoneal tumors of pseudomyxoma peritonei. Orphanet J Rare Dis. 2013 Jul 12;8:105. doi: 10.1186/1750-1172-8-105.
- The American Gut Project is an open-source project to understand the microbial diversity of the human gut.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pseudomyxoma Peritonei
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
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Not yet recruitingPhase 2
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Secondary Malignant Neoplasm of Retroperitoneum, Secondary Malignant Neoplasm of Peritoneum
RecruitingObservational study
Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed
Peritoneal Carcinomatosis, Pseudomyxoma Peritonei
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The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
Appendix Cancer, Pseudomyxoma Peritonei
RecruitingPhase 2
Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Sardi, MD principal investigator
Mercy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-specimen collection and Questionnaire in people with Pseudomyxoma Peritonei and Appendiceal Neoplasm, run by Mercy Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Caitlin King (410-332-9294, mking5@mdmercy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.