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Trial record 64 of 1008 for:    colon cancer AND resection

Studying Lymph Nodes in Patients With Stage II Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00949312
Recruitment Status : Active, not recruiting
First Posted : July 30, 2009
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Wayne Cancer Institute

Tracking Information
First Submitted Date July 29, 2009
First Posted Date July 30, 2009
Last Update Posted Date June 17, 2019
Actual Study Start Date May 2009
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 10, 2014)
Disease-free survival (time to local or distant recurrence after resection) [ Time Frame: 48 months ]
The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer
Original Primary Outcome Measures
 (submitted: July 29, 2009)
  • Disease-free survival (time to local or distant recurrence after resection)
  • Overall survival
Change History Complete list of historical versions of study NCT00949312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 10, 2014)
Overall survival (time to death from colorectal cancer) [ Time Frame: 48 months ]
The event to be used for DFS is time to death after resection of colon cancer
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studying Lymph Nodes in Patients With Stage II Colon Cancer
Official Title Ultrastaging of Early Colon Cancer
Brief Summary

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.

Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Paraffin-embedded primary tumor and lymph node sections
Sampling Method Non-Probability Sample
Study Population From the ambulatory cancer clinic, we will identify 300 stage II colon cancer patients eligible for the study.
Condition Colorectal Cancer
Intervention
  • Genetic: RNA marker analysis of lymph node and primary tumors
  • Genetic: microarray profiling of primary tumors
  • Genetic: reverse transcriptase-polymerase chain reaction of lymph node specimens
  • Other: diagnostic laboratory RNA and DNA biomarker analysis of primary tumors
  • Procedure: regional lymph node dissection
  • Other: lymph node staining for H&E and pancytokeratin IHC
Study Groups/Cohorts Stage II unresected Colon Cancer
Interventions:
  • Genetic: RNA marker analysis of lymph node and primary tumors
  • Genetic: microarray profiling of primary tumors
  • Genetic: reverse transcriptase-polymerase chain reaction of lymph node specimens
  • Other: diagnostic laboratory RNA and DNA biomarker analysis of primary tumors
  • Procedure: regional lymph node dissection
  • Other: lymph node staining for H&E and pancytokeratin IHC
Publications * Protic M, Stojadinovic A, Nissan A, Wainberg Z, Steele SR, Chen DC, Avital I, Bilchik AJ. Prognostic Effect of Ultra-Staging Node-Negative Colon Cancer Without Adjuvant Chemotherapy: A Prospective National Cancer Institute-Sponsored Clinical Trial. J Am Coll Surg. 2015 Sep;221(3):643-51; quiz 783-5. doi: 10.1016/j.jamcollsurg.2015.05.007. Epub 2015 May 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 14, 2019)
26
Original Estimated Enrollment
 (submitted: July 29, 2009)
300
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00949312
Other Study ID Numbers CDR0000649763
UCLA-0809064
BILA-UECC-0107
IRB# 08-09-064-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party John Wayne Cancer Institute
Study Sponsor John Wayne Cancer Institute
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Anton J. Bilchik, MD, PhD, FACS John Wayne Cancer Institute
PRS Account John Wayne Cancer Institute
Verification Date June 2019