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Studying Lymph Nodes in Patients With Stage II Colon Cancer

2022年3月7日 更新者:Saint John's Cancer Institute

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

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

观察性的

注册 (预期的)

26

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

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

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

From the ambulatory cancer clinic, we will identify 300 stage II colon cancer patients eligible for the study.

描述

Inclusion Criteria: All of the following inclusion criteria must be met in order for the subject to be eligible.

  1. Subjects must have CC detected by proctosigmoidoscopy, flexible endoscopy, or gastrograffin/barium enema, with no evidence of distant metastases within 8 weeks of enrollment.
  2. 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.
  3. Greater than 18 years of age
  4. Subjects must have a performance status ≤ 2 on the ECOG/Zubrod scale.
  5. Subject is able to give informed consent, and must be willing to be followed clinically or by phone/email/mail correspondence
  6. Subject must have a life expectancy of greater than 5 years not including the disease/diagnosis of CC.
  7. 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.

  1. 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.
  2. Subjects with any history of Crohn's disease, chronic ulcerative colitis, or familial polyposis.
  3. Discovery of distant metastases intra-operatively.
  4. 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).
  5. 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.
  6. Subjects should not be participating in another research protocol at the time of enrollment. Participation during follow-up is acceptable.
  7. Systemic chemotherapy for node negative colon cancer.
  8. Complete polypectomy by endoscopy
  9. Less than 12 lymph nodes

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

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

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2009年5月1日

初级完成 (预期的)

2023年12月1日

研究完成 (预期的)

2023年12月1日

研究注册日期

首次提交

2009年7月29日

首先提交符合 QC 标准的

2009年7月29日

首次发布 (估计)

2009年7月30日

研究记录更新

最后更新发布 (实际的)

2022年3月9日

上次提交的符合 QC 标准的更新

2022年3月7日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CDR0000649763
  • UCLA-0809064
  • BILA-UECC-0107
  • IRB# 08-09-064-02

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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