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

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ClinicalTrials.gov Identifier: NCT01849107
Recruitment Status : Unknown
Verified May 2013 by Young Seok Kim, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : May 8, 2013
Sponsor:
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
Radiation-induced Small Bowel Toxicity. Biological: Plasma citrulline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2013
Estimated Primary Completion Date : December 2013

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01849107


Contacts
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Contact: Young Seok Kim, Assistant Professor 82-10-5284-2740 ysk@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Young Seok Kim, Assistant professor    82-10-5284-2740    ysk@amc.seoul.kr   
Principal Investigator: Young Seok Kim, Assistant Professor         
Sponsors and Collaborators
Asan Medical Center

Publications:

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Responsible Party: Young Seok Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01849107     History of Changes
Other Study ID Numbers: CTR_SB_2013
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by Young Seok Kim, Asan Medical Center:
Radiation-induced small bowel toxicity
Plasma citrulline