A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors

NCT05136092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-11-06

No results posted yet for this study

Summary

This proposed study is designed to investigate the specific uptake of fructose by human colorectal tumors. In this study, subjects with colorectal cancer undergoing surgery will receive an oral sugar solution containing fructose or xylose prior to surgery. The tumor will then be resected, and a portion of the tissue will be used to measure the abundance of fructose and xylose. The study hypothesis is that the tumors will take up fructose sugar but not xylose sugar. A comparison of the sugar uptake between the tumor and normal tissues from the adjacent intestinal epithelium and smooth muscle and the liver will be conducted. This proposal will confirm that human colorectal cancer tumors can directly absorb dietary sugars, which has never been demonstrated.

Conditions

  • Colorectal Tumors

Interventions

DIETARY_SUPPLEMENT

Cohort 1: HFCS (fructose) fed

Two to three hours before surgery. Subjects will prepare the sugar solutions (Fructose-containing solution: 250 mL of water containing 41.25 g of D-Fructose and 33.75 g of D-Glucose) by adding 250 ml water to the sugar powder provided by the study team and drink it between two and three hours before surgery. Samples collected before surgery: * Blood sample of 5 ml * Urine Samples 5 ml Day of Surgery The anesthesia and surgical procedure will undergo as per regular care. Samples collection at the time the surgical specimen is removed * Blood sample of 5 ml blood will be obtained from the IV line * Tissue samples * 2 Tumor tissue samples 5mmx5mmx5mm, * 2 Intestinal /colon tissue samples 5mmx5mmx5mm * 2 tissue samples from mesentery tissue 5mmx5mmx5mm * Optional Liver Biopsy - a 3-5 mm liver tissue will be obtained for research. * Urine Samples 5 ml

DIETARY_SUPPLEMENT

Cohort 2: D-Xylose (xylose-fed)

Two to three hours before surgery. Subjects will prepare the sugar solutions (Xylose-containing solution: 250 mL of water containing 41.25 g of D-Xylose and 33.75g of D-Glucose) by adding 250 ml water to the sugar powder provided by the study team and drink it between two and three hours before surgery. Samples collected before surgery: * Blood sample of 5 ml * Urine Samples 5 ml Day of Surgery The anesthesia and surgical procedure will undergo as per regular care. Samples collection at the time the surgical specimen is removed * Blood sample of 5 ml blood will be obtained from the IV line * Tissue samples * 2 Tumor tissue samples 5mmx5mmx5mm, * 2 Intestinal /colon tissue samples 5mmx5mmx5mm * 2 tissue samples from mesentery tissue 5mmx5mmx5mm * Optional Liver Biopsy - a 3-5 mm liver tissue will be obtained for research. * Urine Samples 5 ml

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Mehraneh D Jafari, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2024-08-27
Completion
2024-09-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05136092 on ClinicalTrials.gov