2007-02-20
2014-05-22
2014-05-22
9
NCT01445327
National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
OBSERVATIONAL
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 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.
Background: * Gastrointestinal (GI) carcinomas represent one of the most commonly diagnosed malignancies in the United States. * A sensitive and specific marker of tumor persistence or recurrence would permit a more accurate determination of the appropriateness of adjuvant therapy in patients with no clinical evidence of disease following curative resection and allow the diagnosis of recurrences at earlier stages that may be amenable to curative salvage therapies. * A biomarker detectable shortly after treatment or in the early stages of chronic radiation toxicity may allow the identification of patients at risk and early intervention. Objectives: * Our primary objective is to determine if patient specific tumor markers in stool, urine, or serum can be reliably detected prior to treatment and followed after treatment to monitor the extent of residual disease. * A second objective is to evaluate the predictive value of potential markers of chronic gastrointestinal injury after radiotherapy. Eligibility: * Age greater than or equal to 18 years * Histologically confirmed carcinoma of the gastrointestinal tract (esophagus, stomach, pancreas, rectum) * Planned to receive radiotherapy to the site of the gastrointestinal malignancy on an National Cancer Institute (NCI) protocol Design: * This protocol provides a means of acquiring tissue, serum, urine, and stool samples from patients who will receive radiation therapy as part of their treatment for gastrointestinal malignancies. * Patients treated with radiation therapy on NCI treatment protocols will be asked to provide samples prior to any local or systemic therapy as well as before, during and after their radiation treatment. * These samples will be tested for the presence of tumor specific deoxyribonucleic acid (DNA) mutations and aberrant methylation patterns determined to be present in each patient's tumor by screening of initial biopsy or surgical material. * Tumor markers specific to each patient, such as tumor specific DNA mutations or aberrant DNA methylation, may provide an individualized method to evaluate disease status and determine prognosis after therapy. Additionally, a number of stool and serum markers will be explored as early indicators of acute and eventual chronic gastrointestinal injury in patients receiving radiotherapy to the abdomen.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-09-30 | 2021-11-04 | 2022-01-03 |
2011-09-30 | 2022-01-03 | 2022-02-01 |
2011-10-03 | 2022-02-01 | 2022-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Markers of Tumor Burden and Radiation Toxicity Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. | OTHER: Specimen collection |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants With Specific Tumor Markers in Stool, Urine, or Serum Detected Prior to Treatment and After Treatment | 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. | Prior to treatment (baseline) and after treatment, up to 19 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants With Chronic Gastrointestinal Injury After Radiotherapy | Gastrointestinal injury after radiotherapy is influenced by radiation dose (i.e. radiation toxicity) delivered to abdominal organs and can result in gastrointestinal radiation toxicity. Early detection of radiation toxicity (i.e. inflammation, fibrosis) may lead to a good outcome for a participant and late detection and radiation toxicity in the intestinal wall may lead to a bad outcome for a participant. | After radiotherapy, up to 19 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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