Studying Lymph Nodes in Patients With Stage II Colon Cancer
Ultrastaging of Early Colon Cancer
RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease.
PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.
研究概览
地位
条件
干预/治疗
- 程序:区域淋巴结清扫术
- 遗传的:RNA marker analysis of lymph node and primary tumors
- 遗传的:microarray profiling of primary tumors
- 遗传的:reverse transcriptase-polymerase chain reaction of lymph node specimens
- 其他:diagnostic laboratory RNA and DNA biomarker analysis of primary tumors
- 其他:lymph node staining for H&E and pancytokeratin IHC
详细说明
OBJECTIVES:
- Determine whether the immunohistochemical and molecular presence of micrometastases in ≥ 12 lymph nodes removed during en-bloc resection in patients with stage II colon cancer correlates with 3-year disease-free survival.
- Evaluate the prognostic significance of molecular markers detected in the primary tumor and develop a microarray-based gene signature for stage II colon cancer.
OUTLINE: This is a multicenter study.
Tumor tissue and regional lymph node samples are collected during surgery for analysis of micrometastases and molecular markers by immunohistochemistry, qRT-PCR, MM qRT-PCR, qRDNA-PCR, and microarray profiling.
Patients are followed up periodically for 4 years after surgery.
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
California
-
Santa Monica、California、美国、90404
- John Wayne Cancer Institute
-
-
District of Columbia
-
Washington、District of Columbia、美国、20307-5001
- Walter Reed Army Medical Center
-
-
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: All of the following inclusion criteria must be met in order for the subject to be eligible.
- Subjects must have CC detected by proctosigmoidoscopy, flexible endoscopy, or gastrograffin/barium enema, with no evidence of distant metastases within 8 weeks of enrollment.
- Subjects with CC must have a computerized tomography (CT; at a minimum - spiral (helical) CT with 5-mm contiguous reconstruction algorithms and adequate volume (based on site-specific protocols) of oral and intravenous contrast agents) of the abdomen and pelvis and a chest x-ray or CT of the chest per standard of care, within 8 weeks prior to enrollment to rule out distant metastases. Subjects with preoperative CT scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may be eligible pending intraoperative exploration.
- Greater than 18 years of age
- Subjects must have a performance status ≤ 2 on the ECOG/Zubrod scale.
- Subject is able to give informed consent, and must be willing to be followed clinically or by phone/email/mail correspondence
- Subject must have a life expectancy of greater than 5 years not including the disease/diagnosis of CC.
- Subject must have clinical assessment conducted by phone unless patients follow up are part of the regular clinical visits.
Exclusion Criteria: Any of the following criteria will exclude the subject from the study.
- Subjects requiring emergent surgery (within 2 hours of presentation) to prevent a life-threatening situation or death such as those with a perforated colon, metabolically significant complete bowel obstruction or massive GI bleeding will be excluded. Subjects who do not require emergent surgery, such as those with occult bleeding or early or partial bowel obstruction will be permitted to enter.
- Subjects with any history of Crohn's disease, chronic ulcerative colitis, or familial polyposis.
- Discovery of distant metastases intra-operatively.
- Subjects with history of another malignancy over the last three years (except for completely resected cervical, skin cancers or in-situ cancers - see Appendix B for a list of exempt cancers).
- Pregnant and/or lactating women. Potentially childbearing subjects (pre-menopausal women) should undergo a pregnancy test within 7 days prior to surgery and after signing consent. Subjects found to be pregnant will be ineligible and withdrawn from the study.
- Subjects should not be participating in another research protocol at the time of enrollment. Participation during follow-up is acceptable.
- Systemic chemotherapy for node negative colon cancer.
- Complete polypectomy by endoscopy
- Less than 12 lymph nodes
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 |
|---|---|
|
Stage II unresected Colon Cancer
|
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 |
|---|---|---|
|
Disease-free survival (time to local or distant recurrence after resection)
大体时间:48 months
|
The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer
|
48 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival (time to death from colorectal cancer)
大体时间:48 months
|
The event to be used for DFS is time to death after resection of colon cancer
|
48 months
|
合作者和调查者
调查人员
- 首席研究员:Anton J. Bilchik, MD, PhD, FACS、Saint John's Cancer Institute
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
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