Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03230240 |
| Other study ID # |
MMC2015-62 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2016 |
| Est. completion date |
October 2020 |
Study information
| Verified date |
September 2020 |
| Source |
MercyOne Des Moines Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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).
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.
