Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity

January 8, 2020 updated by: Young Seok Kim, Asan Medical Center
Small bowel irradiation results in epithelial cell loss and consequently impairs function and metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The investigators evaluate the correlation between plasma citrulline level, dose-volume histogram of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a biomarker for quantifying radiation-induced epithelial cell loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed cancer patients
  • Appropriate liver, renal, and bone marrow function for radiotherapy
  • Willing to provide informed written consent
  • At least 20 years old

Exclusion Criteria:

  • prior abdominopelvic radiation therapy or chemotherapy or abdominal surgery
  • Any contraindication to radiotherapy (i.e. Severe connective tissue disorder, etc.)
  • Prior or simultaneous history of other malignancy
  • On medication for small bowel disease or CTCAE 4.0 Grade 1 or higher toxicity before radiation
  • Any treatment delay more than 1 week during radiotherapy
  • No radiotherapy due to any other reason except small bowel toxicity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Plasma citrulline
Biological: Plasma citrulline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation coefficient between plasma citrulline and dose-volume histogram of small bowel.
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Correlation coefficient between plasma citrulline and toxicity grade by CTCAE 4.0
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

April 28, 2013

First Submitted That Met QC Criteria

May 5, 2013

First Posted (ESTIMATE)

May 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTR_SB_2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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