跳至主要内容
临床试验/NCT05025878
NCT05025878招募中不适用

Metabolic Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients

British Columbia Cancer Agency1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Achieve [U-13C]Glucose enrichment in the ascites of ovarian cancer patients

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Ovarian cancer
  • Any stage or grade of disease
  • Ascites fluid that requires draining
  • Any treatment regimen
  • Primary or recurrent ascites
  • Understands the concept of the study and give informed consent.

排除标准

  • Participants must not have diabetes or abnormal hemoglobin A1C levels.
  • The patient's glucose levels must be between 4 - 11.1 mM before administering an infusion. This is to ensure that patients are within normal blood glucose levels, as described by Diabetes Canada.
  • Participants cannot receive chemotherapy treatment during the 5 hour duration of the experiment as it may compromise the integrity of the data.

结局指标

主要结局

Achieve [U-13C]Glucose enrichment in the ascites of ovarian cancer patients

时间窗: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)

Extracellular \[U-13C\]Glucose label enrichment in the ascites fluid (measured by mass spectrometry).

Compare glucose uptake and metabolic pathways in different cell populations in the ascites.

时间窗: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)

Fractional enrichment of intracellular \[U-13C\]Glucose and 13C labeled metabolites in T cells, myeloid cells and tumour cells (measured by mass spectrometry).

次要结局

  • Correlate metabolic profiles with functionality of T cells found in the ascites.(One time - Duration of ascites paracentesis)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验