Immunologic Profile of Peritoneal Cancer

September 20, 2020 updated by: Jan Franko, MD, MercyOne Des Moines Medical Center

Immunologic, Cellular, and Anti-microbial Profiling of Intraperitoneal Chemotherapy

To ascertain immunologic profile of peritoneal cavity and its relationship to immediate postsurgical outcome (morbidity or the treatment) and long-term outcome (time to recurrence and survival).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. BACKGROUND:

    Tumor-host interaction includes inactivation of immunologic recognition of malignant cells by a mechanism yet not fully understood. Aneuplodity studies on cells from different metastatic sites demonstrate increased heterogeneity depending on metastatic site (Kimball 1997). This suggests that phenotypically different cell populations are responsible for different metastases and may demonstrate different sensitivity/resistance to treatment. Kitayama (2015) studied ratio of lymphocytes to epithelial cell in peritoneal cavity, but used this ratio only as marker of tumor burden and did not relate it to perioperative outcome.

    Investigators have clinically observed a different behavior of peritoneal metastases as compared to those located in other body sites (Franko 2012, Klaver 2012, Franko 2016). It is hypothesized that tumor-host interaction and host-treatment response are related to treatment-related morbidity, early vs. delayed recurrence, and overall survival.

    There is a limited literature and research examining the immunologic profile of intraperitoneal chemotherapy and its relationship to morbidity and future metastatic sites. Therefore, further knowledge of the biology of different peritoneal surface metastatic disease is necessary. This, with additional research, may lead to specific therapies.

  2. OBJECTIVES:

    To ascertain immunologic profile of peritoneal cavity and its relationship to immediate postsurgical outcome (morbidity or the treatment) and long-term outcome (time to recurrence and survival).

  3. STUDY POPULATION:

    Patients with peritoneal carcinomatosis undergoing intraperitoneal chemotherapy.

    3.1 Exclusion criteria: Under age of 18 years, pregnant patients, those unable to provide consent.

  4. SUBJECT RECRUITMENT METHODS:

    All patients scheduled to undergo cytoreductive procedure for peritoneal carcinomatosis in at Mercy Medical Center in Des Moines, IA (MMC). This study will be offered during a preoperative office or a hospital visit by Dr Franko or Dr Goldman.

  5. INFORMED CONSENT:

    Attached

  6. RESEARCH PROCEDURES:

    Liquid samples will be collected and analyzed. We will collect ascites, peritoneal washout, HIPEC perfusion fluid. Samples will be analyzed using flow cytometry, routine fluid cytology, and tested for anti-microbial properties.

    6.1 Sample labeling:

    The following peritoneal fluid sample will be collected:

    A - ascites or peritoneal saline washout at the beginning of case B - HIPEC fluid after pre-heating and immediately before chemotherapy agent provision C, D, E - HIPEC fluid at 30, 60, and 90 minutes of perfusion 6.2 Flow cytometry Fluid samples will be run through flow cytometry to analyze proportion of CD3, CD4, CD8, CD20, CD34 positive cells.

    6.3 Cytology Routine cytology of peritoneal fluid represents standard of care for malignant disease diagnostics and will be conducted as per usual diagnostic plan.

    6.4 Detection of anti-microbial properties Fluid samples will be introduced to bacterial growth in the microbiology laboratory at MMC. Growth inhibition of standard bacterial strains (Staphylococcus aureus, Escherichia coli) will be recorded. The samples will also be sent for flow cytology and possibly chromatography to measure exact concentrations of chemotherapeutic agent remaining in samples.

    6.5 High-performance liquid chromatography A limited number of samples will be analyzed with high performance liquid chromatography to determine exact chemotherapy concentration remaining in sample (den Hartigh 1981). This part of the research is conducted in collaboration with Dr. Brian Gentry at Drake University. Sample provided for this part of research will be deidentified, date-time-stamped, and Drake's team will receive no other clinical or demographic information. Re-identification at MMC remains possible.

    To satisfy methodological needs, we will collect each case will provide 2 samples: Sample B will be a HIPEC perfusate solution at the completion of initial heating up period collected before adding chemotherapy agent. Sample E will be perfusate at the completion of HIPEC procedure expected to contain MMC. Sample E is the main research sample. Sample volume is 5 cc.

  7. DATA COLLECTION AND ANALYSIS:

    Sample B is obtained before active treatment agent is provided to the solution. It represents a small withdrawal volume of 5 cc out of approximately 3-5 liter HIPEC solution used in usual case. Average clinical dosing of carrier solution is 2 liters/m2 of patient's body surface area, therefore representing < 0.2% total HIPEC carrier solution volume. Sample C & D represent the same volume, but are withdrawn from patient with active treatment. Given very small volume of each sample no negative effect is expected, as total sample volume is <0.6% total HIPEC perfusion fluid.

    All other research samples are derived only from residual surgical specimen exclusively obtained for treatment purposes. Data collection will include, but is not limited to, patient name, gender, age, initial tumor stage, current tumor stage & extent, histology, prior treatment modalities, and results from flow cytometry, microbiology, and HPLC, and medical record for 60 months following surgery.

  8. POTENTIAL RISKS:

    8.1 Risks related to sampling: Some body fluid samples are collected on residual surgical specimens removed from patient for treatment purpose (samples A and E), and are independent of research. The exception are Sample B,C,D - the only samples removed from patient for research purpose only. The volume of each sample is minute, < 0.2% of total perfusate volume; therefore total sampling volume in ≤0.6% expected perfusate volume. Given these two facts it is reasonable to assume no expected influence on patients' outcome.

    8.2 Risks related to loss of confidentiality Because identifiable data are collected there is a potential risk of breach of confidentiality. To protect confidentiality and minimize risk, research data will be maintained on MMC computers with access restricted to the core research team and password-protected file. Privacy laws will be maintained.

  9. RESEARCH MATERIALS, RECORDS, AND PRIVACY:

    Research database will be maintained on MMC computers with privileged access restricted to the core research team and password-protected file. Privacy laws will be maintained.

  10. CONFIDENTIALITY:

No research specimen will be stored. All research specimens will be destroyed in accordance with usual laboratory procedures.

Electronic data will be maintained until the last analysis is carried out. Access to the data will be limited to authorized personnel associated with this study.

The samples provided to Drake University are deidentified and cannot be re-identified by Drake University team. Therefore no confidentiality loss there is expected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • MercyOne Des Moines Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with peritoneal carcinomatosis undergoing intraperitoneal chemotherapy.

Description

Inclusion Criteria:

  • HIPEC pt

Exclusion Criteria:

  • absent consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HIPEC
Patients with carcinomatosis or other peritoneal surface malignancy
Drug: HIPEC
heated intraIP chemotherapy
Other Names:
  • Hyperthermic intraperitoneal chemotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
In vitro growth of Staph Aureus and Escherichia coli measured in millimeters of colony forming unit on Agar plate
Time Frame: 1 year after operation
1 year after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MercyOne Des Moines Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Franko, MD, PhD, MercyOne Des Moines Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MMC2015-62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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