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NCT01445327 · ClinicalTrials.gov registry record
Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers
A clinical trial, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- 9
- Enrollment target
NCT01445327: Clinical Trial study, sponsored by National Cancer Institute (NCI).
NCT01445327 is a clinical trial that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445327 was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- 9 participants
- Enrollment target
Study 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 com
Primary Outcome
Here are the number of participants with specific tumor markers in stool, urine, or serum detected prior to treatment and after treatment to monitor the extent of residual disease.
Interventions
- OTHER Specimen collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2007-02-20 |
| Est. Completion | 2014-05-22 |
Why NCT01445327 stopped before completion
NCT01445327 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Specimen collection is the first listed.
NCT01445327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01445327 about?
NCT01445327 is a clinical study titled "Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers". 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 t...
What is the current status of trial NCT01445327?
This trial is currently terminated. The enrollment target is 9 participants. The study started on 2007-02-20. Estimated completion is 2014-05-22.
What interventions are being tested in trial NCT01445327?
The interventions under investigation include: Specimen collection (OTHER).
Who is sponsoring clinical trial NCT01445327?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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