Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer
The goal of this laboratory research is to look for genes that can predict which patients will achieve a complete disappearance of their colorectal cancer after treatment like chemotherapy, radiation, or other therapy.
This is an investigational study. Up to 350 patients will take part in this study. All will be enrolled at MD Anderson.
研究概览
详细说明
Patients with colorectal cancer usually receive radiation, chemotherapy, or other therapy before they have surgery. At this time, there are no tests that can help researchers find out which patients no longer have any tumor left after completing treatment. Because of this, all patients have to have surgery to completely remove the rectum and/or part of the colon. This procedure results in lifestyle changes for the patient, which may be difficult and permanent.
Researchers are looking for new ways to find out which patients will have no tumor left after treatment, so that in the future, some patients may be able to avoid surgery altogether. In this study, researchers will try to use chemical "markers" in tumor cells as a way to possibly predict whether or not the tumor is likely to disappear with treatment alone.
At MD Anderson, all patients with colorectal cancer have an endoscopy performed by their surgeon as part of standard care, before they start therapy. Endoscopy involves placing a narrow tube in the colon and/or rectum in order to see and inspect the tumor.
If you choose to take part in this study, tissue samples will be taken from the tumor and the normal areas during your standard endoscopy. If you undergo surgery, tissue samples from the tumor(s) and normal areas will also be collected. At the time of endoscopy and/or surgery, once the doctor has finished all standard tests on this tissue and has received the clinical reports on these tests, any leftover tissue samples will be collected by Dr. You or a person on her research team for research tests to look for tumor cell "markers." Researchers want to find out how these markers may have changed since you began receiving treatment for the disease.
Some of the tissue from your biopsies may also be sent to the labs at University of Texas-Southwest or Natera for testing. No identifying information about you will be included with these samples. They will have a special number assigned, so that the samples being sent to UT Southwest or Natera will not be able to be connected to you in any way.
The results of these tests will not be used to make any decisions regarding treatment of your rectal cancer. There are no other tests or procedures required in this study
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Yi-Qian N. You, MD
- 电话号码：713-792-6940
- 邮箱：YNYou@mdanderson.org
学习地点
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Texas
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Houston、Texas、美国、77030
- 招聘中
- University of Texas MD Anderson Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with colorectal adenocarcinoma (diagnosis based on either MDACC or outside records)
- Patients scheduled to undergo neoadjuvant therapy per MDACC care team.
- Patients over 18 years of age.
- Patients with distant organ findings deemed to be indeterminate or metastatic will be enrolled at the surgeon's discretion.
- Patients who have been deemed medically safe to undergo endoscopic biopsy by the physician performing the procedure.
- Patients who would have typically undergone preoperative therapy followed by surgery but for specific reasons at the discretion of the treating physician underwent surgery without preoperative therapy may be enrolled at the surgeons' discretion.
Exclusion Criteria:
N/A
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Colorectal Cancer
Participants undergo standard endoscopy before therapy.
Tissue samples taken from the tumor and normal colorectal tissue.
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Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Predictive Tumor Cell Biomarkers After Chemoradiation Treatment for Colorectal Cancer
大体时间：1 day
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Tissue taken at endoscopy undergoes testing for tumor cell biomarkers to identify patients who achieve complete response (CR).
|
1 day
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.