13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.

NCT05025878 | Recruiting

• 1 other identifier: H18-03615
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer; Ascites

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

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

Secondary Outcomes (1)

• Correlate metabolic profiles with functionality of T cells found in the ascites.

  One time - Duration of ascites paracentesis

Study Arms (1)

[U-13C]glucose

All participants consented to the study will receive the \[U-13C\]glucose infusion and collection of ascites for research.

Dietary Supplement: [U-13C]Glucose

Interventions

[U-13C]Glucose DIETARY_SUPPLEMENT

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.

[U-13C]glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults over the age of 18 with ascites due to diagnosed ovarian cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• University of Texas Southwestern Medical Center: collaborator
• Van Andel Research Institute: collaborator
• University of Victoria: collaborator

Study Sites (1)

Jennifer Rauw

Victoria, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Ascites

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Julian J. Lum, PhD

CONTACT

250-519-5700; JLum@bccancer.bc.ca

Jennifer Rauw, MD

CONTACT

250-519-5500; Jennifer.Rauw@bccancer.bc.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 27, 2021
• Study Start: October 20, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CA (1)