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CompletedNCT00896753Updated May 30, 2017

Gene Expression Profiling in Normal Tissue and Tumor Tissue From Patients With Colon Cancer That Has Spread to the Liver, Lungs, or Peritoneum

An observational study in Colorectal Cancer and Metastatic Cancer, sponsored by Wake Forest University Health Sciences. Completed. Open to participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Wake Forest University Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
Up to 120 Years
Sex
All
01

Study summary

RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or peritoneum.

Read the detailed description

OBJECTIVES:

  • Evaluate gene expression profiles in normal and tumor tissue from patients with colon cancer metastatic to the liver, lungs, or peritoneum.
  • Establish cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum.
  • Determine the specific gene expression changes that result in the manifestation of the drug-resistant phenotype for each metastatic site.

OUTLINE: This is a pilot study.

Tumor and normal tissue collected during surgery are analyzed for gene expression profiling by cDNA microarray. Tissue is also analyzed for thymidylate synthase (TS) gene expression by quantitative PCR and for protein expression by western blot. Gene expression patterns are correlated with TS levels.

02

Conditions studied

  • Colorectal Cancer
  • Metastatic Cancer

Keywords

  • stage IV colon cancer
  • liver metastases
  • lung metastases
  • recurrent colon cancer
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's enrollment of 10 is below the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Browse Wake Forest University Health Sciences studies →

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

04

Who can participate

Ages eligible
Up to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with metastatic colen cancer

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colon cancer metastatic to the liver, lungs, or peritoneum

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (actual)

Groups and cohorts

  • patients with metastatic colon cancer
06

What researchers measure

Primary outcomes

  1. Gene expression changes that occur at each metastatic site (i.e., liver, lungs, and peritoneum)

    Time frame: day 1

  2. Development of cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum

    Time frame: day 1

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2003, a primary completion of Sep 2006 and a completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2009
First posted
May 12, 2009
Start
Sep 2003
Primary completionActual
Sep 2006
CompletionActual
May 2008
Last update
May 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00896753
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Sep 2003
Primary completion
Sep 2006
Completion
May 2008
Last update
May 30, 2017

Study contacts

Perry Shen, MD
study chair · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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