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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on collecting biological samples from patients with advanced ovarian cancer to aid biomarker research. Biomarkers serve as indicators that enhance understanding of the disease and guide treatment decisions. The trial collects samples such as blood, tumor tissue, and other fluids like ascites fluid. It suits patients diagnosed with stage III or IV high-grade serous ovarian, tubal, or primary peritoneal cancer who are willing to provide samples. Doctors may use the test results to plan participants' treatment. As an unphased trial, this study allows patients to contribute to important research that could improve future treatment strategies.

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 these sample collection methods are safe?

Research has shown that collecting samples such as blood, tumor tissue, and fluids from patients is generally safe. Studies have found that taking blood samples is a routine procedure with very low risk. For collecting tumor tissue, research indicates that imaging techniques are safe and practical for patients with ovarian cancer.

For collecting ascites, which involves draining fluid from the abdomen, one study found a high success rate with few complications when using a flexible tube. This method is often used for patients with recurring fluid buildup.

Overall, these procedures are common in medical settings and have been shown to be safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on collecting various biological samples from ovarian cancer patients, which could lead to more personalized and effective treatments in the future. Unlike current treatment options, such as surgery and chemotherapy, this approach doesn't directly treat the cancer but aims to gather detailed data on the disease. By analyzing tumor tissue, blood, and other fluid samples, scientists hope to discover new biomarkers that can provide insights into how ovarian cancer develops and progresses. This could eventually lead to breakthroughs in early detection and targeted therapies, offering hope for better outcomes for patients.

What evidence suggests that this trial's sample collection methods could be effective for biomarker research in ovarian cancer?

Research has shown that collecting samples such as blood, tumor tissue, and abdominal fluid enhances the understanding of ovarian cancer. In this trial, participants will undergo sample collection, which may include tumor tissue, blood, and ascites samples. Specifically, collecting abdominal fluid can temporarily relieve symptoms in about 94% of patients. Blood samples are crucial for identifying early cancer signs, aiding in earlier detection. Tumor tissue samples also help identify these signs, offering doctors a clearer picture of the disease. These methods provide valuable information that can guide treatment decisions and potentially improve outcomes. ^{1 2 5 6 7}

Who Is on the Research Team?

Amit Oza, MD

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

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.

Have a life expectancy greater than or equal to 6 months

I am fully active or can carry out light work.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4673904/

Meeting the challenge of ascites in ovarian cancer ... ascites and evidence for their use is weak. Phase II data suggest that they are effective in approximately one-third of patients with malignancy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8430600/

Malignant Ascites in Ovarian Cancer: Cellular, Acellular, and ... [17] reported that a mean of 94% of patients treated with paracentesis had temporary relief of symptoms when compiling data from five different cancer studies.

3. withpower.com withpower.com/trial/phase-2018-18264

Biomarker Sampling for Ovarian Cancer What data supports the effectiveness of the treatment Ascites Collection and related procedures for ovarian cancer? The research indicates that paracentesis ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04032600

Malignant Ascites in Ovarian Cancer: Impact of Total ... The ATLANTIS-study was designed to determine the safety of a full paracentesis in patients with malignant ascites due to ovarian cancer.

5. molecular-cancer.biomedcentral.com molecular-cancer.biomedcentral.com/articles/10.1186/s12943-025-02438-z

Harnessing ovarian cancer ascites for translational science This review summarizes the current understanding of ovarian cancer ascites with a focus on, (1) etiology, (2) cytopathological and molecular ...

6. ocrahope.org ocrahope.org/news/ascites-ovarian-cancer/

Ascites and Ovarian Cancer If ascites keeps recurring, some women with ovarian cancer opt to get a flexible tube inserted into the space where the fluid is.

7. emedicine.medscape.com emedicine.medscape.com/article/80944-overview

Paracentesis: Background, Indications, Contraindications Paracentesis is a procedure in which a needle or catheter is inserted into the peritoneal cavity to obtain ascitic fluid for diagnostic or therapeutic purposes.