NCT01286883

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 20, 2018

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

January 28, 2011

Last Update Submit

August 16, 2018

Conditions

Colorectal Cancer

Keywords

stem cell markersprognostic markersmetastatic colorectal cancercirculating tumor cellstumor microenvironmentcolorectal canceradvanced colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint: correlation of stem cell markers on CTCs with response to therapy

    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

    3 years

Secondary Outcomes (1)

  • Secondary Outcome: Correlation of stem cell markers in primary tumors with stem cell markers in CTCs

    3 years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic colorectal cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Allen JE, El-Deiry WS. Circulating Tumor Cells and Colorectal Cancer. Curr Colorectal Cancer Rep. 2010 Oct 1;6(4):212-220. doi: 10.1007/s11888-010-0069-7.

    PMID: 20890370BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wafik S El-Deiry, MD, PhD

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

January 31, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2014

Study Completion

September 1, 2014

Last Updated

August 20, 2018

Record last verified: 2017-01

Locations

US(1)