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Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers

NCT01445327 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2022-02-01

Study results available
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Summary

Background:

* Gastrointestinal cancers are among the most commonly diagnosed cancers in the United States.
* There are currently no tests to predict how patients with gastrointestinal cancers will respond to radiation therapy or which patients may develop side effects from treatment.
* Studies on tumor cells in the stool, urine, or blood from patients may provide valuable information that can be used to develop tests to determine which patients may need more or less aggressive therapy.
* Studies of other substances in the stool, urine, or blood from patients may provide valuable information that can be used to develop tests to determine which patients are likely to develop side effects from radiation treatments.

Objectives:

* To collect blood, urine and stool specimens from patients with gastrointestinal cancers who will undergo radiation therapy.
* To study hormone and protein changes in these blood, urine and stool specimens before, during and after radiation treatment in order to develop a way to predict how gastrointestinal cancers will respond to radiation therapy and if patients with these cancers will develop side effects from radiation treatment.

Eligibility:

-Patients 18 years of age and older with cancer of the gastrointestinal tract (esophagus, stomach, pancreas, rectum) who plan to receive radiotherapy to the site of the cancer on an National Cancer Institute (NCI) protocol

Design:

Participants undergo the following procedures:

* Tumor biopsy: Before any treatment or at the time of surgery if it is the first treatment
* Urine collection: Before, during, and after treatment and at follow-up visits.
* Stool collection: Before, during, and after treatment and at follow-up visits.
* Blood collection: Before, during, and after treatment and at follow-up visits.
* Intestinal permeability assessment: Before any treatment, before radiation (if radiation is not the first treatment), 1 month after radiation is completed, and 3 months after radiation is completed. This test determines how the patients intestines are working to absorb sugar and may provide information about side effects from radiation treatments. Patients fast after midnight, then drink a small glass of sugars, and then do a 6-hour urine collection.

Conditions

Interventions

OTHER

Specimen collection

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Deborah E Citrin, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-20
Primary Completion
2014-05-22
Completion
2014-05-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01445327 on ClinicalTrials.gov