Biospecimen Collection for Peritoneal Cancer

Overseen By University of California Irvine Medical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Non-compliance

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to collect blood and tissue samples from patients with gastrointestinal (GI) tumors to better understand peritoneal cancer, which affects the abdominal lining. Researchers hope these samples will yield valuable insights into the disease, potentially leading to new treatments. This trial suits individuals with a GI tumor already scheduled for surgery as part of their standard care. Participants will provide samples during their planned surgical procedure. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could pave the way for future advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this biospecimen collection is safe?

This study involves collecting samples, such as blood and tumor tissue, from individuals with certain types of cancer. It does not test a new drug or treatment. Instead, the study aims to gather samples to enhance understanding of cancer.

Collecting blood and tissue samples is generally safe. These procedures are common during surgeries and assist doctors in understanding diseases better. Participants might experience some discomfort or minor risks, such as a bruise from blood collection, but these are usually well-tolerated.

For those who have had blood drawn or surgery, the process is similar. The focus is on collecting samples during a surgery already scheduled, with no new treatments being tested.

Why are researchers excited about this trial?

Researchers are excited about the biospecimen collection for peritoneal cancer because it focuses on gathering important biological samples like blood, peritoneal wash fluid, and tumor samples. Unlike standard treatments that mainly focus on eradicating cancer cells through surgery, chemotherapy, or radiation, this approach aims to deepen our understanding of the disease at a molecular level. By analyzing these biospecimens, scientists hope to uncover new insights into peritoneal cancer, potentially leading to more effective, targeted treatments in the future. This method represents a shift from just treating the cancer to understanding its underlying mechanisms, which could revolutionize how we approach this condition.

What evidence suggests that this biospecimen collection is effective for peritoneal cancer research?

This study does not test a treatment but collects samples to better understand peritoneal cancer. Research on these samples, such as blood and tumor tissue, can help scientists learn more about cancer mechanisms. By examining these samples, researchers aim to identify patterns or signs that could lead to better treatments in the future. The goal is to gather information that might improve diagnosis or treatment options later. While this study does not directly test a treatment, it aims to support future cancer research.

Who Is on the Research Team?

Maheswari Senthil, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with peritoneal carcinomatosis originating from gastrointestinal tumors, who are scheduled for standard surgical procedures. They must be able to understand and sign consent forms. Those unable to follow the study protocol cannot participate.

Inclusion Criteria

My cancer started in the GI tract and has spread to the lining of my abdomen.

I am scheduled for a standard surgery recommended for my condition.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

Patients who are unable to comply with the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants provide blood, ascites/peritoneal wash fluid, and tumor samples during their planned surgical procedure

1 day

1 visit (in-person)

In Vitro Model Development

Development of individual patient-derived peritoneal carcinomatosis (pdPC) vascularized micro-tumor (VMT) models

14 days

Follow-up

Participants are monitored for safety and effectiveness after sample collection and model development

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection

Trial Overview The study involves collecting biospecimens such as blood, ascites/peritoneal wash fluid, and tumor samples during planned surgeries of patients with gastrointestinal peritoneal carcinomatosis.

How Is the Trial Designed?

Group I: Subjects with Gastrointestinal Primary Tumor with or without Peritoneal Carcinomatosis Experimental Treatment 1 Intervention

Subjects with gastrointestinal (GI) primary tumor with or without peritoneal carcinomatosis who are undergoing planned standard of care (SOC) surgical procedures. Biospecimens such as blood, peritoneal wash fluid and tumor samples will be obtained.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

Pleural and peritoneal fluids can be valuable for biobanking, potentially providing less invasive alternatives to traditional tissue samples for clinical analyses.

The study outlines techniques for effectively collecting and banking these fluids, which could support targeted therapies through liquid biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procurement and Storage of Pleural and Peritoneal Fluids for Biobanking. Marchevsky, AM., Bose, S., Knudsen, B.[2019]

A new microfluidic chip platform was developed to enrich ascites tumor cells (ATCs) from ovarian cancer patients, allowing for less invasive monitoring of treatment responses compared to traditional biopsies.

In a study of 47 patients, the ATCdx marker set was identified as a reliable method to quantify ATC numbers and assess treatment responses, demonstrating its potential for improving clinical care and drug development in ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ascites analysis by a microfluidic chip allows tumor-cell profiling. Peterson, VM., Castro, CM., Chung, J., et al.[2021]

A study involving 51 healthcare professionals revealed that many are concerned about handling antineoplastic drugs (ADs), with 29.4% expressing fear and only 5.9% having received training on AD handling during their initial education.

The study found that HIPEC is perceived to pose a higher risk of exposure to ADs compared to PIPAC, with 81.6% of participants agreeing, and protective equipment was considered less suitable for HIPEC, indicating a need for improved training and safety measures in handling these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception, knowledge and protective practices for surgical staff handling antineoplastic drugs during HIPEC and PIPAC. Benoist, H., Eveno, C., Wilson, S., et al.[2022]

A consensus was reached among 40 stakeholders in endometrial cancer research on standardized tools for the collection, processing, and storage of biospecimens, which is crucial for ensuring the reliability of scientific data.

The developed tools are freely available and aim to enhance collaboration and efficiency in endometrial cancer research, potentially accelerating advancements in understanding and treating this common gynecological cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harmonisation of biobanking standards in endometrial cancer research. Adishesh, M., Fyson, A., DeCruze, SB., et al.[2018]

The ISSPP PIPAC online database was successfully launched in June 2020, collecting data on 459 PIPAC procedures from 181 patients across 10 institutions, which helps standardize documentation and improve acceptance of this treatment method.

This international registry aims to enhance the understanding of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for peritoneal malignancies, providing a platform for future randomized trials and improving patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ISSPP PIPAC database: design, process, access, and first interim analysis. Mortensen, MB., Glehen, O., Horvath, P., et al.[2022]

Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) shows a low mortality rate of 1% and a manageable grade III-IV morbidity rate of 12.5%, indicating it is a safe treatment option for selected patients with peritoneal carcinomatosis.

Overall survival rates vary significantly based on the histological type of cancer, with median survival times of 47.6 months for ovarian cancer, 45.8 months for colorectal cancer, and 64.2 months for peritoneal mesothelioma, highlighting the importance of cancer type in prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity, mortality, and oncological outcomes of 401 consecutive cytoreductive procedures with hyperthermic intraperitoneal chemotherapy (HIPEC). Desantis, M., Bernard, JL., Casanova, V., et al.[2022]

In a study of 23 patients with advanced epithelial ovarian cancer who underwent neoadjuvant chemotherapy, the reduction in the Peritoneal Cancer Index (PCI) score after treatment was found to be the most reliable predictor for achieving complete cytoreduction (CCR).

A decrease of at least 8.5 points in the PCI score was more indicative of successful CCR than simply achieving a PCI score below 25, suggesting that the PCI should be evaluated differently in patients receiving neoadjuvant treatment compared to those undergoing primary surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of the Peritoneal Cancer Index (PCI) to predict surgical outcome after neoadjuvant chemotherapy in advanced ovarian cancer. Rawert, FL., Luengas-Würzinger, V., Claßen-Gräfin von Spee, S., et al.[2022]

A novel exosome gene signature, ExoSig445, was identified from plasma exosomes of 42 colon cancer patients, including those with peritoneal carcinomatosis, demonstrating a clear distinction from healthy controls.

This exosomal RNA analysis achieved 100% accuracy in classifying cancer patients versus healthy individuals, suggesting that ExoSig445 could serve as a highly sensitive liquid biopsy test for colon cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma Exosome Gene Signature Differentiates Colon Cancer from Healthy Controls. Vallejos, PA., Gonda, A., Yu, J., et al.[2023]

In a study of 132 patients undergoing 383 PIPAC procedures, 3% experienced severe hypersensitivity reactions to platinum compounds, highlighting a rare but significant risk associated with this treatment.

All reported hypersensitivity reactions were successfully managed without complications, indicating that while the reactions are serious, they can be effectively treated when they occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe hypersensitivity reactions to platinum compounds post-pressurized intraperitoneal aerosol chemotherapy (PIPAC): first literature report. Siebert, M., Alyami, M., Mercier, F., et al.[2019]

Peritoneal cancer (PC) is more aggressive than advanced-stage ovarian cancer (OC), with patients experiencing earlier relapse-free survival, indicating a need for different treatment approaches for these distinct cancer types.

Molecular analysis revealed that PC has a unique gene expression profile and different predictive markers for chemotherapy response compared to OC, suggesting that personalized treatment strategies should consider the specific type of cancer and tumor location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-grade serous peritoneal cancer follows a high stromal response signature and shows worse outcome than ovarian cancer. Jacob, F., Marchetti, RL., Kind, AB., et al.[2021]

Cell-free KRAS mutant DNA was detected in 40% of malignant peritoneal fluids from patients with peritoneal carcinomatosis, indicating its potential as a biomarker for disease burden.

The study found that lower mutant allele frequencies (MAF) of cell-free KRAS DNA were associated with patients whose disease was amenable to cytoreductive surgery, suggesting that MAF could help predict surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peritoneal Cell-Free Tumor DNA as Biomarker for Peritoneal Surface Malignancies. Leick, KM., Kazarian, AG., Rajput, M., et al.[2022]

In a study of 147 patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, the overall postoperative complication rate was 37%, with a mortality rate of 2%.

The Clavien-Dindo classification system identified a significantly higher rate of major morbidity (25%) compared to the CTCAE classification (8%), suggesting that the Clavien-Dindo system may provide a clearer and more user-friendly assessment of surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where Oncologic and Surgical Complication Scoring Systems Collide: Time for a New Consensus for CRS/HIPEC. Lehmann, K., Eshmuminov, D., Slankamenac, K., et al.[2022]

Citations