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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01849107
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : January 13, 2020
Information provided by (Responsible Party):
Young Seok Kim, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diarrhea Anorexia Dyspepsia Biological: Plasma citrulline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Plasma citrulline Biological: Plasma citrulline

Primary Outcome Measures :
  1. 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 ]

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

Other Outcome Measures:
  1. Correlation coefficient between plasma citrulline and toxicity grade by CTCAE 4.0 [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01849107

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center

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Responsible Party: Young Seok Kim, Assistant Professor, Asan Medical Center Identifier: NCT01849107    
Other Study ID Numbers: CTR_SB_2013
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Keywords provided by Young Seok Kim, Asan Medical Center:
Radiation-induced small bowel toxicity
Plasma citrulline
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms