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CompletedNCT00414492Updated Sep 16, 2010

Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer

An observational study in Metastatic Colorectal Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-16.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

Systemic chemotherapy for metastatic colon cancer is often used in the neoadjuvant setting for patients undergoing liver resection. This treatment is given either to keep the tumor at bay or reduce its size before the time of resection. While many metastatic tumors might appear to respond well and even radiographically disappear following neoadjuvant therapy, it is unclear whether grossly or radiographically negative areas of previous disease are microscopically free of tumor cells. As such, when possible, resection boarders typically follow 1 cm margins from the tumor size prior to neoadjuvant therapy. These margins might be necessary to encompass all histologically present disease or they might be unnecessarily large, serving only to increase the mortality and morbidity of the operation. This study begins to address this question by a histological examination of the pattern of cell death in areas of metastases removed after neoadjuvant therapy. Furthermore, clinical cases in which neoadjuvant therapy allowed for resection of previously unresectable cancer will be examined to determine whether there is an increased rate of recurrence despite "negative" resection boundaries in these cases.

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Conditions studied

  • Metastatic Colorectal Cancer

Keywords

  • metastatic colorectal cancer
  • liver metastasis
  • tumor margins
  • neoadjuvant therapy
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 100 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with colon cancer metastases to the liver

Inclusion criteria

  • Patients must be ≥ 18 years old.
  • Patients must have colon cancer metastases to the liver.
  • Patients must be candidates and be scheduled for liver resection.
  • Patients must have received and have had a response to neoadjuvant therapy prior to liver resection.
  • Patients must have signed Institutional Review Board (IRB) approved written consent form prior to registering in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients who are \< 18 years old.
  • Patients who do not have colon cancer metastases to the liver.
  • Patients who are not surgical candidates.
  • Patients who do not schedule or who cancel a liver resection.
  • Patients who have not received neoadjuvant therapy.
  • Patients who have received neoadjuvant therapy but who have had no response or who have had tumor progression.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Biospecimen retention
Samples with dna
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Study locations

1 site
  • Johns Hopkins Medicine
    Baltimore, Maryland 21287, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00414492
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
First posted
Dec 21, 2006
Start date
Dec 2006
Completion
Jun 2010
Last update
Sep 16, 2010

Study contacts

Michael A Choti, MD
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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