An observational study in Ovarian Cancer and Ascites, sponsored by British Columbia Cancer Agency. Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by British Columbia Cancer Agency · Observational
The objective of the study is to investigate the metabolism of cells in the ascites tumour microenvironment of ovarian cancer patients. This observational study involves intravenous infusion of [U-13C]glucose into patients during standard paracentesis.
Participants and Location:
This study will recruit up to 10 patients of at least 18 years of age with ascites due to diagnosed ovarian cancer. Eligible study patients will be screened and recruited at BC Cancer - Victoria. Paracentesis procedure and patient consent will occur at the Island Health - Royal Jubilee Hospital.
Study Design:
Participants meeting the inclusion criteria will be fitted with a continuous glucose monitor (FreeStyle Libre) before proceeding to their scheduled appointment for paracentesis. Labeled glucose will be administered via I.V. at dose of 8g of labeled glucose in 60 mL over 10 min. This is followed by 4g of labeled glucose in 30 mL over an hour.
Sample collection and processing:
During [U-13C]glucose infusions, the ascites specimens will kept on ice. Samples will be collected and analyzed by flow cytometry and mass spectrometry for states of metabolism and metabolite profiles respectively. The ascites fluid will be monitored for changes in metabolite levels.
[U-13C]glucose Product Information:
[U-13C]glucose clinical grade will be compound BC Cancer Pharmacy.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 10 is below the median of 200 across 616 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →British Columbia Cancer Agency is the lead sponsor of 152 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults over the age of 18 with ascites due to diagnosed ovarian cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants consented to the study will receive the \[U-13C\]glucose infusion and collection of ascites for research.
Dietary Supplement: [U-13C]Glucose
Patients are intravenously infused with 28g of \[U-13C\]glucose over a 5 hour period. Briefly, \[U-13C\]glucose will be provided by intravenous line containing 8g of \[U-13C\]glucose in 60 mL over 10 min. After 10 minutes, 4g of \[U-13C\]glucose will be administered over an hour. This process will continue until the patient's ascites is drained, or after 5 hours. We will monitor blood glucose levels during infusions using a continuous glucose monitor.
Achieve [U-13C]Glucose enrichment in the ascites of ovarian cancer patients
Extracellular \[U-13C\]Glucose label enrichment in the ascites fluid (measured by mass spectrometry).
Time frame: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Compare glucose uptake and metabolic pathways in different cell populations in the ascites.
Fractional enrichment of intracellular \[U-13C\]Glucose and 13C labeled metabolites in T cells, myeloid cells and tumour cells (measured by mass spectrometry).
Time frame: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Correlate metabolic profiles with functionality of T cells found in the ascites.
Multi-parametric flow cytometry analysis of glucose uptake, mitochondrial function, T cell phenotypes and function.
Time frame: One time - Duration of ascites paracentesis
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