Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
Wafik El-Deiry, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01286883
First received: January 28, 2011
Last updated: January 3, 2014
Last verified: January 2014

January 28, 2011
January 3, 2014
February 2011
November 2014   (final data collection date for primary outcome measure)
Primary endpoint: correlation of stem cell markers on CTCs with response to therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Correlate the presence of stem cell markers and prognostic markers on circulating tumor cells with response to therapy for advanced colorectal cancer, as well as overall survival
Same as current
Complete list of historical versions of study NCT01286883 on ClinicalTrials.gov Archive Site
Secondary Outcome: Correlation of stem cell markers in primary tumors with stem cell markers in CTCs [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate the primary tumor if available for stem cell markers and prognostic markers. Perform genomic analysis of CTC DNA. Compare genomic analysis of primary tumor and CTC DNA. Evaluate CTC gene expression profiles and compare with primary tumor profiles. Evaluate emerging microfluidic devices in pilot studies that use drops of blood for CTC analysis.
Same as current
Not Provided
Not Provided
 
Cancer Stem Cell Markers and Prognostic Markers in Circulating Tumor Cells
Prevalence of Stem Cell and Prognostic Markers in Circulating Tumor Cells of Patients With Metastatic Colorectal Cancer Undergoing Chemotherapy

The study will enroll patients with metastatic colorectal cancer receiving chemotherapy. A total of approximately 22 cc of blood will be drawn during various chemotherapy infusions. Additional proposed laboratory studies may unravel important biological insights into the relationship of circulating tumor cell genomic and genetic profiles as they compare to the primary tumors. Additionally the investigators hope to gain an understanding of potential subgroups of patients that have very high numbers of circulating tumor cells or those with early relapse of circulating tumor cells after early reduction of circulating tumor cell numbers.

Metastatic colorectal cancer (mCRC) has a five year survival of <10% and is the cause of death of nearly 50,000 individuals in the United States each year. Current first and second line therapies for mCRC include FOLFOX, XELOX, or FOLFIRI in combination with Bevacizumab or Cetuximab or Panitumumab, as well as Xeloda, camptosar or infusional 5-FU within various less intensive regimens for patients who cannot tolerate full-dose chemotherapy. Current practice involves evaluation of response by imaging at 2-3 months after initiation of therapy. Recent studies have demonstrated that the number of circulating tumor cells (CTCs) in the blood of patients with mCRC has independent prognostic value in terms of reflecting disease burden as well as indicating response to therapy. The use of CTC counts offers the possibility of predicting response in treated patients at an earlier time than through standard means by using CT scans. The investigators hypothesize that subsets of CTCs with cancer stem cell (CSC) markers or other known prognostic markers may improve the prognostic value of CTC evaluation in the course of therapy of patients with mCRC. The protocol will use Veridex CellSearch technology and will when possible compare this to other emerging technologies including microfluidic devices that can isolate CTCs or GFP-expressing adenoviruses that replicate in telomerase-expressing epithelial tumor cells ex-vivo. The protocol will enroll 200 patients with metastatic colorectal cancer receiving therapy. Additional proposed laboratory studies may unravel important biological insights into the relationship of CTC genomic and genetic profiles as they compare to the primary tumors. Additionally the investigators hope to gain an understanding of potential subgroups of patients that have very high numbers of CTCs or those with early relapse of CTC after early reduction of CTC numbers. The impact of this research may be in better prediction of response to mCRC therapy so that patients can be treated with second line or other experimental therapy if they are unlikely to respond to their current therapy as predicted by CTC evaluation.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood will be drawn at 7 different time intervals to analyze CSC and other prognostic markers on circulating tumor cells.

Non-Probability Sample

Patients with metastatic colorectal cancer

Colorectal Cancer
Not Provided
Blood draws
Laboratory studies will be performed at baseline; Cycle 1, Day 1; Cycle 1, Day 7; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 6, Day 1; Cycle 12, Day 1.
Allen JE, El-Deiry WS. Circulating Tumor Cells and Colorectal Cancer. Curr Colorectal Cancer Rep. 2010 Oct 1;6(4):212-220.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with the diagnosis of metastatic colorectal cancer, either newly diagnosed or recurrent, with measurable disease that has not been irradiated within the last 5 weeks.
  • Age > 18 years old
  • ECOG performance status 0-3

Exclusion Criteria:

  • Patients who have received prior therapy in the last 5 weeks
  • Ongoing therapy with a particular regimen that was initiated prior to enrollment and lack of availability of baseline CTC evaluation
  • Patient with concurrent diagnosis of other active solid malignancies will be exclude
  • Patient life expectancy of less than six weeks
Both
18 Years and older
No
Contact: Wafik S El-Deiry, MD, PhD 717-531-5059 wafik.eldeiry@gmail.com
Contact: David Dicker 717-531-5101 dtd2@psu.edu
United States
 
NCT01286883
PSHCI 10-066, PSHMC IRB No. 34902EP
Yes
Wafik El-Deiry, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: Wafik S El-Deiry, MD, PhD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP