Peritoneal Cancer Clinical Trial
Official title:
Study of Plasma Tumor-promoting Factors and Immune Function After Explorative Laparotomy, Tumor Debulking and HIPEC (Hyperthermic Intraperitoneal Chemotherapy) vs. PIPAC (Pressurized IntraPeritoneal Aerosol Chemothereapy) in Patients With Peritoneal Metastasis as Evaluated by Serum Proliferative Activity, Levels of Proteins, Cytokines, Circulating Growth Factors, Inhibitors and Their Binding Proteins.
The general goal of this study is to investigate the effect of treatment on serum
concentrations of proteins known to impact angiogenesis or tumor growth and establishment in
patients with peritoneal metastasis of various origin. Since the immune system is thought, by
many, to have an impact on tumor growth and development, this study also seeks to determine
the impact of abdominal surgery on postoperative immune function in PM patients, as judged by
proteins known to influence immune function. This study will not only characterize the
postoperative plasma but also to determine if the magnitude of any of the changes noted is
associated with a worse or improved oncologic outcome.
The principle purpose of this study is to gather perioperative serum/plasma samples from
patients with PM from a variety of different primary tumors (ovarian, gastric, and
colorectal) undergoing either CRS and HIPEC versus PIPAC.
The plasma samples obtained in this protocol will also be used to study the various plasma
proteins that influence immune function as well as those that influence angiogenesis. In
addition to the proteins mentioned above, there are also a large number of other proteins
that have not been investigated thus far in the perioperative window; these proteins also
merit assessment. The plasma obtained via this study and protocol will also be used to search
for other tumor growth factors influenced by surgery or to investigate the impact of surgery
on immune function.
Aim 1: To determine perioperative serum levels, over time, of a variety of serum proteins
including but not limited to IGFBP-3, VEGF, Ang 2, PlGF, sVCAM, CHI3L1, MMP-2, MMP-3, MCP-1
and proteins that influence immune function as well as other proteins in the following 2
groups of patients:
1. PM patients treated with CRS and HIPEC
2. PM patients treated with PIPAC.
Aim 2: To compare the perioperative blood protein results between the 2 different groups of
patients.
Aim 3: To determine, within each group, a possible correlation between the magnitude of these
effects on oncological outcome (patient overall survival).
Aim 4: To search for other surgery-influenced plasma or cellular factors that may influence
early postoperative tumor growth or that hold promise as tumor or prognostic markers.
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