Biomarker Sampling for Ovarian Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Disqualifiers: Early stage cancer, Other histology, Biopsy contraindication
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
23567How 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.
12389Eligibility 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
+5 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.
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Kingston Health Sciences CentreKingston, Canada
London Health Sciences CentreLondon, Canada
The Ottawa Hospital Cancer CentreOttawa, Canada
Sunnybrook Health Sciences CentreToronto, Canada
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Assessing Genetic Variants in Matched Biocompartments From Patients With Serous Ovarian Cancer. [2021]The clinical use of molecular tumor profiling (MTP) is expanding and there is an increasing use of MTP data to manage patient care. At the University of Colorado, 18 patients were diagnosed with primary serous ovarian cancer between 9/2015 and 6/2019 and consented for banking and analysis of tumor, ascites and plasma. All 18 patients had tumor and plasma samples that were sent for MTP, and 13 of 18 patients additionally had ascites collected and sent for MTP. 50-gene panel testing and BRCA testing were performed on primary tumor. BRCA genetic variants were more likely to be identified in plasma as compared to ascites or tumor, though not statistically significant (P = 0.17). Co-occurring genetic variants between plasma and ascites were less common in comparison to co-occurring variants between tumor and plasma or tumor and ascites, though not statistically significant (P = 0.68). Variants in KDR (VEGFR2) and TP53 were most likely to be conserved across all 3 biocompartments. Mutant allele frequencies (MAF) of individual genetic variants varied across biocompartments, though tended to be highest in the tumor, followed by ascites.
A novel technique for the enrichment of primary ovarian cancer cells. [2015]Primary cancer cells that are extracted from ovarian tumors can serve as an optimal substrate to study the biologic characteristics of ovarian cancer. We describe an efficient and effective method of enriching ovarian tumor cells from ascitic fluid using an immunomagnetic-based method.
Ascites as a predictor of ovarian malignancy. [2022]To determine the utility of ascites as a predictor of ovarian malignancy and define its relationship with the histologic type of ovarian tumor (benign, borderline, or malignant) and stage of disease.
Ovarian cancer and ascites: A questionnaire on current management in the United kingdom. [2016]A questionnaire on ovarian cancer ascites management was sent to members of the British Gynaecological Cancer Society (BGCS), the National Gynaecological Oncology Nurses, and the Assoication of Palliative Medicine. Questions were asked on diuretics, hematologic investigations, paracentesis, and duration of stay. Nine hundred ninety-five questionnaires were distributed, of which 492 replies were received (49% response rate). Fifty-five percent of responders used paracentesis as first-line management of ovarian cancer ascites (15% diuretics). Seventy-five percent performed some blood tests in relation to paracentesis. Ultrasound was used by 43.6% during paracentesis (15.7% for direct visualization, 27.9% to mark an entry site). Seventy-seven percent used a Bonanno catheter. Eighty-three percent used no intravenous fluids during paracentesis, and there was a wide variation in the amount and rate of drainage of ascites (1 L maximum up to free drainage of all ascites, median 5 L; 0.5 L per hour to free drainage). Gynecologists tended to use more interventions (paracentesis, ultrasound, and intravenous fluids) than palliative care physicians or medical oncologists, while palliative care physicians used fewer interventions but admitted patients for longer periods of time. This identified several areas for future study: the value of hematologic investigations, the use of outpatient management for paracentesis, and the use of ultrasound and the rate of drainage of ascites.
Processing and Analysis of Ascites. [2023]The accumulation of peritoneal fluid, referred to as ascites, is common in ovarian cancer. This fluid is a complex mixture that may include cells as well as a diverse array of cytokines and growth factors. Here we describe a comprehensive method to process ascites to maximize data collection. The cellular fraction and fluid are first separated by centrifugation. The fluid can be frozen for later analysis of soluble factors or for use in in vitro experiments. The cellular fraction can be processed to analyze its composition or stored for future use.
Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study. [2022]Paracentesis is commonly undertaken in patients with cancer-related ascites.
Primary culture of ovarian surface epithelial cells and ascites-derived ovarian cancer cells from patients. [2015]Our laboratory has refined the technique for isolating primary cultures of normal human ovarian surface epithelial (OSE) cells by combining two different protocols involving the enzymatic and mechanical removal of OSE cells from ovarian biopsies. A simple protocol of obtaining primary epithelial ovarian cancer (EOC) cells from the ascites fluid removed from patients with high-grade ovarian cancer is also described. These methods allow for the direct application of many molecular and cellular analyses of normal versus cancer cells isolated freshly from patients, with the added potential for retrospective analyses of archived cells and tissues. Thus, we have included optional steps for the immediate preparation of ascites-derived EOC cells to be used for subsequent cytological analyses. Initial isolation of OSE or EOC cells can be completed in 1 h, and primary cells are further expanded in culture for several weeks.
Ascites analysis by a microfluidic chip allows tumor-cell profiling. [2021]Ascites tumor cells (ATCs) represent a potentially valuable source of cells for monitoring treatment of ovarian cancer as it would obviate the need for more invasive surgical biopsies. The ability to perform longitudinal testing of ascites in a point-of-care setting could significantly impact clinical trials, drug development, and clinical care. Here, we developed a microfluidic chip platform to enrich ATCs from highly heterogeneous peritoneal fluid and then perform molecular analyses on these cells. We evaluated 85 putative ovarian cancer protein markers and found that nearly two-thirds were either nonspecific for malignant disease or had low abundance. Using four of the most promising markers, we prospectively studied 47 patients (33 ovarian cancer and 14 control). We show that a marker set (ATCdx) can sensitively and specifically map ATC numbers and, through its reliable enrichment, facilitate additional treatment-response measurements related to proliferation, protein translation, or pathway inhibition.
Cytology of peritoneal implants of borderline serous tumor of ovaries in ascitic fluid. [2022]Peritoneal fluid cytology is done routinely in cases with serous carcinoma of ovary. However, morphologic features of borderline serous tumors (BSTs) of ovary in ascitic fluid have been rarely described. The aim of our study was to evaluate the morphologic features of BST with and without ascitic fluid involvement (BST+ and BST-, respectively) and compare with those of serous carcinomas, both in conventional and liquid-based cytology (LBC) smears.