510 Participants Needed

Biomarker Sampling for Ovarian Cancer

Recruiting at 6 trial locations
Amit Oza, MD profile photo
Overseen ByAmit Oza, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.23567

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.12389

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

Dr. Amit Oza | Bras DDP

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
See 4 more

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
1Treatment groups
Experimental Treatment
Group I: Sample CollectionExperimental Treatment4 Interventions
The following samples may be collected during the study: * Tumour tissue samples * Blood samples * Ascites samples * Other fluids requiring drainage

Find a Clinic Near You

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

References

Assessing Genetic Variants in Matched Biocompartments From Patients With Serous Ovarian Cancer. [2021]
A novel technique for the enrichment of primary ovarian cancer cells. [2015]
Ascites as a predictor of ovarian malignancy. [2022]
Ovarian cancer and ascites: A questionnaire on current management in the United kingdom. [2016]
Processing and Analysis of Ascites. [2023]
Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study. [2022]
Primary culture of ovarian surface epithelial cells and ascites-derived ovarian cancer cells from patients. [2015]
Ascites analysis by a microfluidic chip allows tumor-cell profiling. [2021]
Cytology of peritoneal implants of borderline serous tumor of ovaries in ascitic fluid. [2022]
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