Clinical trial · Observational
Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers
A Pilot Study of Markers of Tumor Burden and Radiation Toxicity in the Blood, Urine, and Stool of Patients Receiving Radiotherapy for Gastrointestinal Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow, insufficient accrual.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Specimen collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Markers of Tumor Burden and Radiation Toxicity
- description
- Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.
- interventionNames
- Other: Specimen collection
Primary outcomes (1)
- measure
- Number of Participants With Specific Tumor Markers in Stool, Urine, or Serum Detected Prior to Treatment and After Treatment
- timeFrame
- Prior to treatment (baseline) and after treatment, up to 19 months
- description
- 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.
Secondary outcomes (1)
- measure
- Number of Participants With Chronic Gastrointestinal Injury After Radiotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Age greater than or equal to 18 years. * Histologically confirmed carcinoma of the gastrointestinal tract (esophagus, stomach, pancreas, bile duct, rectum). * Treatment plan includes radiotherapy to the site of the gastrointestinal malignancy on an National Cancer Institute (NCI) protocol. * Paraffin embedded tumor tissue from biopsy or surgery adequate in amount to perform polymerase chain reaction (PCR) and methylation specific PCR or willingness to undergo re-biopsy. EXCLUSION CRITERIA: * Inability to provide informed consent. * Patients who have a history of prior therapeutic radiation. * Patients with evidence of distant metastases on initial staging evaluation. * Patients with other cancers excluding non-melanomatous skin cancers or carcinoma in situ. * History of inflammatory bowel disease. * History of collagen vascular disease or disease of altered collagen metabolism (end stage renal disease or hepatic fibrosis due to chronic hepatitis). * History of hypersensitivity to radiation or a history of a disease which results in mucosal or other hypersensitivity to radiation (Ataxia-Telangiectasia, Bloom's Syndrome, Human Immunodeficiency Virus, Fanconi anemia, nevoid basal cell carcinoma syndrome, Li-Fraumeni syndrome, and Nijmegen breakage syndrome). * Inability to return for follow-up visits. * Patients who have previously received or are currently receiving MDX-101 (ipilimumab). * Diagnosis of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
References
Publications (3)
- BACKGROUNDJemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106. PMID 16514137
- BACKGROUNDSeamonds B, Yang N, Anderson K, Whitaker B, Shaw LM, Bollinger JR. Evaluation of prostate-specific antigen and prostatic acid phosphatase as prostate cancer markers. Urology. 1986 Dec;28(6):472-9. doi: 10.1016/0090-4295(86)90146-9. PMID 2431533
- BACKGROUNDGuillet J, Role C, Duc AT, Francois H. Prostate-specific antigen (PSA) in the management of 500 prostatic patients. Am J Clin Oncol. 1988;11 Suppl 2:S61-2. doi: 10.1097/00000421-198801102-00013. PMID 2468274