HIPEC For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis ‐ Data Registry
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/27/2018 |
Start Date: | February 2014 |
End Date: | January 2034 |
Contact: | Kathy Seymour, BSN |
Email: | Kathy.Seymour@EEHealth.org |
Phone: | 630-646-6072 |
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis ‐ Data Registry
In this registry study the investigators will collect data about patients' disease,
treatment, and response to treatment to include in both our local and national databases.
These can then be used by investigators to answer questions about cytoreductive surgery/HIPEC
such as how well-tolerated or effective it is in specific populations.
treatment, and response to treatment to include in both our local and national databases.
These can then be used by investigators to answer questions about cytoreductive surgery/HIPEC
such as how well-tolerated or effective it is in specific populations.
Patient Selection: The sole inclusion criteria for this study will be those consenting
patients who are to undergo cytoreductive surgery followed by HIPEC.
Data Collection and Use Plan: For those patients who provide informed consent, data listed
below will be collected during and after treatment. This will be entered into the PI's local
database for future use and, after being de-identified, will be shared with a national
database (held by the American Society of Peritoneal Surface Malignancies) to bolster the
amount available for researchers looking at efficacy and outcomes such as overall survival
rates, progression-free survival, and tolerability in certain populations.
Data Collected (as applicable): Age, primary tumor, dates of prior surgeries, prior
chemotherapy with dates and whether it was neoadjuvant in nature, length of disease status,
comorbidities, Peritoneal Surface Disease Severity Score, Peritoneal Cancer Index as
determined prior to surgery, Peritoneal Cancer Index as determined during surgery,
Completeness of Cytoreduction score, ascites present, blood products used, complications,
length of stay in ICU and in hospital, where discharged, death within 30 days, readmission
and reason, date of recurrence, treatment of recurrence, and time from procedure to death.
For the HIPEC surgical procedure itself, data collected will be: date, duration,
chemotherapeutic used and dose, duration of circulation, fluid temp, and flow rate.
patients who are to undergo cytoreductive surgery followed by HIPEC.
Data Collection and Use Plan: For those patients who provide informed consent, data listed
below will be collected during and after treatment. This will be entered into the PI's local
database for future use and, after being de-identified, will be shared with a national
database (held by the American Society of Peritoneal Surface Malignancies) to bolster the
amount available for researchers looking at efficacy and outcomes such as overall survival
rates, progression-free survival, and tolerability in certain populations.
Data Collected (as applicable): Age, primary tumor, dates of prior surgeries, prior
chemotherapy with dates and whether it was neoadjuvant in nature, length of disease status,
comorbidities, Peritoneal Surface Disease Severity Score, Peritoneal Cancer Index as
determined prior to surgery, Peritoneal Cancer Index as determined during surgery,
Completeness of Cytoreduction score, ascites present, blood products used, complications,
length of stay in ICU and in hospital, where discharged, death within 30 days, readmission
and reason, date of recurrence, treatment of recurrence, and time from procedure to death.
For the HIPEC surgical procedure itself, data collected will be: date, duration,
chemotherapeutic used and dose, duration of circulation, fluid temp, and flow rate.
Inclusion Criteria:
- Eligible to undergo cytoreductive surgery followed by HIPEC performed by the PI at
Edward Hospital
- Provides consent by signing informed consent form
Exclusion Criteria:
- Not eligible for surgery or for potential cytoreductive surgery and/or HIPEC as
determined by the PI
- Does not consent to participate
We found this trial at
2
sites
Elmhurst, Illinois 60126
Principal Investigator: George I Salti, MD
Phone: 630-646-6072
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Naperville, Illinois 60566
Principal Investigator: George I Salti, MD
Phone: 630-646-6072
Click here to add this to my saved trials