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

Trial Summary

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 data supports the effectiveness of the treatment Biospecimen Collection for Peritoneal Cancer?

The research suggests that collecting peritoneal fluids and cell-free tumor DNA can help measure disease burden and guide targeted therapies, which may improve treatment outcomes for peritoneal cancer. ^{1 2 3 4 5}

Is biospecimen collection for peritoneal cancer safe for humans?

Research on related procedures like pressurized intraperitoneal aerosol chemotherapy (PIPAC) and hyperthermic intraperitoneal chemotherapy (HIPEC) shows a generally favorable safety profile, though there are reports of severe allergic reactions to certain drugs used in these treatments. ^{6 7 8 9 10}

How does this treatment for peritoneal cancer differ from other treatments?

This treatment involves collecting and analyzing peritoneal fluids, which is less invasive than traditional tissue biopsies. It uses liquid biopsies to potentially guide targeted therapies, making it unique compared to standard treatments that often rely on more invasive procedures. ^{1 3 5 11 12}

What is the purpose of this trial?

This is a pilot study gathering and using samples and data from patients with gastrointestinal peritoneal carcinomatosis. Participants will be asked for permission to provide blood and ascites/peritoneal wash fluid, tumor samples during their planned surgical procedure.

Research Team

Maheswari Senthil, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

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

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

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.

Exclusion Criteria

Patients who are unable to comply with the study protocol

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Peritoneal Cell-Free Tumor DNA as Biomarker for Peritoneal Surface Malignancies. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

High-grade serous peritoneal cancer follows a high stromal response signature and shows worse outcome than ovarian cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Plasma Exosome Gene Signature Differentiates Colon Cancer from Healthy Controls. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

The importance of the Peritoneal Cancer Index (PCI) to predict surgical outcome after neoadjuvant chemotherapy in advanced ovarian cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Procurement and Storage of Pleural and Peritoneal Fluids for Biobanking. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Where Oncologic and Surgical Complication Scoring Systems Collide: Time for a New Consensus for CRS/HIPEC. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Perception, knowledge and protective practices for surgical staff handling antineoplastic drugs during HIPEC and PIPAC. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

The ISSPP PIPAC database: design, process, access, and first interim analysis. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Severe hypersensitivity reactions to platinum compounds post-pressurized intraperitoneal aerosol chemotherapy (PIPAC): first literature report. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Morbidity, mortality, and oncological outcomes of 401 consecutive cytoreductive procedures with hyperthermic intraperitoneal chemotherapy (HIPEC). [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Ascites analysis by a microfluidic chip allows tumor-cell profiling. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Harmonisation of biobanking standards in endometrial cancer research. [2018]