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.
調査の概要
状態
条件
介入・治療
- 手順:所属リンパ節郭清
- 遺伝的:RNA marker analysis of lymph node and primary tumors
- 遺伝的:microarray profiling of primary tumors
- 遺伝的:reverse transcriptase-polymerase chain reaction of lymph node specimens
- 他の:diagnostic laboratory RNA and DNA biomarker analysis of primary tumors
- 他の:lymph node staining for H&E and pancytokeratin IHC
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
California
-
Santa Monica、California、アメリカ、90404
- John Wayne Cancer Institute
-
-
District of Columbia
-
Washington、District of Columbia、アメリカ、20307-5001
- Walter Reed Army Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Stage II unresected Colon Cancer
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease-free survival (time to local or distant recurrence after resection)
時間枠:48 months
|
The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer
|
48 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival (time to death from colorectal cancer)
時間枠:48 months
|
The event to be used for DFS is time to death after resection of colon cancer
|
48 months
|
協力者と研究者
捜査官
- 主任研究者:Anton J. Bilchik, MD, PhD, FACS、Saint John's Cancer Institute
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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