Biomarker Sampling for Ovarian Cancer

Recruiting at 6 trial locations

Overseen By Amit Oza, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Early stage cancer, Other histology, Biopsy contraindication

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

Compensation: Varies

Number of Visits: Unknown

510 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 Ascites Collection and related procedures for ovarian cancer?

The research indicates that paracentesis (a procedure to remove fluid from the abdomen) is commonly used as a first-line treatment for managing ascites in ovarian cancer patients, with 55% of surveyed healthcare providers in the UK using it. Additionally, the analysis of ascites fluid can help identify genetic variants and tumor characteristics, which may aid in personalizing treatment for ovarian cancer. ^{1 2 3 4 5}

Is biomarker sampling for ovarian cancer safe for humans?

The procedures involved in biomarker sampling, such as paracentesis (removal of fluid from the abdomen) and blood sample collection, are commonly performed and generally considered safe in humans. These methods are routinely used in medical practice, including for patients with cancer-related conditions, and have established safety profiles. ^{2 3 5 6 7}

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

This treatment is unique because it involves biomarker sampling from ascitic fluid, which allows for less invasive monitoring of ovarian cancer compared to traditional surgical biopsies. The use of a microfluidic chip to analyze ascites can help track treatment response and disease progression more effectively. ^{1 2 3 8 9}

What is the purpose of this trial?

This is a sample study that will collect biological samples (blood, tumor tissue, ascites, and/or other fluids) from gynecological cancer patients for biomarker research. In addition, the results of the testing done on the samples will be given to the participant's treating physician who may use the information to guide treatment decisions.

Research Team

Amit Oza, MD

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

This study is for adults with advanced high-grade serous ovarian, tubal, or primary peritoneal cancer. Participants must be in good physical condition (ECOG 0-1), have a life expectancy of at least 6 months, and be willing to provide tissue samples during surgery or from existing tumor archives.

Inclusion Criteria

I have been diagnosed with advanced high grade serous ovarian, tubal, or peritoneal cancer.

I am fully active or can carry out light work.

Have a life expectancy greater than or equal to 6 months

Exclusion Criteria

I can safely undergo tumor biopsy and blood sampling.

My cancer is not early stage high grade serous, tubal, or peritoneal.

My cancer is high grade serous.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Collection of biological samples such as tumor tissue, blood, ascites, and other fluids for biomarker research

Ongoing during study participation

Follow-up

Participants are monitored for genomic and immune signatures in terms of overall and progression-free survival

10 years

Treatment Details

Interventions

• Ascites Collection
• Blood Sample Collection
• Fluid Collection
• Tumour Tissue Collection

Trial Overview The trial involves collecting blood, tumor tissue, ascites (fluid in the abdomen), and other fluids from patients to find biomarkers that could help guide future treatment decisions. The collected data may also inform the patient's current treatment plan.

Participant Groups

Group I: Sample Collection Experimental Treatment 4 Interventions

The following samples may be collected during the study: * Tumour tissue samples * Blood samples * Ascites samples * Other fluids requiring drainage

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 18 patients with primary serous ovarian cancer, molecular tumor profiling (MTP) was used to analyze tumor, plasma, and ascites samples, highlighting its expanding role in patient care management.

BRCA genetic variants were more frequently detected in plasma samples compared to tumor or ascites, suggesting plasma may be a valuable source for genetic testing in ovarian cancer, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Genetic Variants in Matched Biocompartments From Patients With Serous Ovarian Cancer. Sanders, BE., Ku, L., Walker, P., et al.[2021]

An efficient immunomagnetic method was developed to enrich ovarian tumor cells from ascitic fluid, significantly increasing tumor cell purity from an average of 22.8% to 82.3% in samples from 6 ovarian cancer patients.

This technique allows for the study of primary cancer cells, which may provide more clinically relevant insights compared to traditional cancer cell lines, enhancing our understanding of ovarian cancer biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel technique for the enrichment of primary ovarian cancer cells. Chan, JK., Hamilton, CA., Anderson, EM., et al.[2015]

In a study of 125 patients with pelvic masses, the presence of ascites was found to be a strong predictor of ovarian malignancy, with a positive predictive value of 95% for detecting malignant tumors.

The study also revealed a clear relationship between the stage of ovarian cancer and the presence and volume of ascites, with advanced stages (III and IV) showing a significantly higher incidence (89%) and greater volume (>0.5 liters) of ascites compared to early stages (I and II).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ascites as a predictor of ovarian malignancy. Shen-Gunther, J., Mannel, RS.[2022]

A survey of 492 healthcare professionals revealed that 55% use paracentesis as the first-line treatment for ovarian cancer ascites, while only 15% rely on diuretics, indicating a preference for invasive management.

There is significant variability in the management of ascites, including the amount and rate of fluid drainage, highlighting the need for standardized protocols and further research on outpatient paracentesis and the role of ultrasound in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer and ascites: A questionnaire on current management in the United kingdom. Macdonald, R., Kirwan, J., Roberts, S., et al.[2016]

Ascites, a fluid accumulation common in ovarian cancer, contains a mix of cells, cytokines, and growth factors, which can provide valuable insights into the disease.

The study presents a detailed method for processing ascites, allowing for effective separation and analysis of its cellular and fluid components, which can enhance future research on ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processing and Analysis of Ascites. Micek, HM., Carroll, MJ., Barroilhet, L., et al.[2023]

In a study of 111 patients with cancer-related ascites, 81% experienced symptom improvement immediately after paracentesis, particularly in abdominal distension, pain, and nausea.

While most patients benefited from the procedure, 36% experienced some harm, including serious complications like bowel perforation, highlighting the need for careful consideration of risks and benefits in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study. Seah, DS., Wilcock, A., Chang, S., et al.[2022]

The study presents refined techniques for isolating primary cultures of normal human ovarian surface epithelial (OSE) cells and epithelial ovarian cancer (EOC) cells, allowing for detailed molecular and cellular analyses of these cells directly from patient samples.

The isolation process can be completed in just 1 hour, with the ability to expand primary cells in culture for several weeks, facilitating both immediate and retrospective studies of ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary culture of ovarian surface epithelial cells and ascites-derived ovarian cancer cells from patients. Shepherd, TG., Thériault, BL., Campbell, EJ., et al.[2015]

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]

In a study of 21 cases (7 borderline serous tumors with ascitic fluid involvement, 7 without, and 7 serous adenocarcinomas), distinct cytomorphological features were identified that can help differentiate borderline serous tumors from serous carcinomas in ascitic fluid.

Borderline serous tumors exhibited regular papillary fragment borders and mild-to-moderate nuclear pleomorphism, while serous carcinomas showed irregular borders and more severe nuclear pleomorphism, suggesting that careful cytological examination can improve detection of these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytology of peritoneal implants of borderline serous tumor of ovaries in ascitic fluid. Sharma, S., Mohapatra, DS., Gupta, N., et al.[2022]

References

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

Assessing Genetic Variants in Matched Biocompartments From Patients With Serous Ovarian Cancer. [2021]

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

A novel technique for the enrichment of primary ovarian cancer cells. [2015]

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

Ascites as a predictor of ovarian malignancy. [2022]

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

Ovarian cancer and ascites: A questionnaire on current management in the United kingdom. [2016]

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

Processing and Analysis of Ascites. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Primary culture of ovarian surface epithelial cells and ascites-derived ovarian cancer cells from patients. [2015]

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

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

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

Cytology of peritoneal implants of borderline serous tumor of ovaries in ascitic fluid. [2022]