NCT01196130

Brief Summary

The goal of this clinical research study is to test for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical "markers" in the tumor tissue and/or blood that may be related to your reaction to cancer drugs. This is an investigational study. This study's biomarker testing is for research purposes only. Up to 1280 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

12.4 years

First QC Date

September 3, 2010

Last Update Submit

December 12, 2022

Conditions

Colorectal Cancer

Keywords

Metastatic colorectal cancerCRCColorectal adenocarcinomaBiomarker determinationTumor tissueTreatment protocols

Outcome Measures

Primary Outcomes (1)

  • Rate of Successful Biomarker Determination

    Descriptive analysis performed to report the frequency of informative biomarkers for each of the companion allocation biomarkers as a proportion of patients enrolled onto the study. The primary analysis will be number of patients where informative biomarker results were determined for all tested biomarkers divided by the total number of patients enrolled on the study. Results reported separately for each of the individual biomarkers. Reasons for non-informative results reported descriptively.

    +/- 7 days

Study Arms (1)

Biomarker Assessment

Leftover sample of tumor tissue from a previous procedure used for biomarker testing. Blood drawn for biomarker testing, to check for levels of cytokines, and to check the circulating tumor cells (CTCs). Cancer Symptom Questionnaire completion about cancer symptoms.

Behavioral: Cancer Symptom QuestionnaireOther: Biomarker Testing

Interventions

Cancer Symptom QuestionnaireBEHAVIORAL

5 minute questionnaire(s) completed at each study visit.

Biomarker Assessment
Biomarker TestingOTHER

Blood draw at each study visit for biomarker and cytokine testing.

Biomarker Assessment

Eligibility Criteria

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

Patients previously treated with systemic chemotherapy for metastatic colorectal cancer.

You may qualify if:

  • The patient has a histologically or cytologically confirmed colorectal adenocarcinoma with metastatic or unresectable, locally advanced disease documented on diagnostic imaging studies.
  • The patient must have been previously treated with systemic chemotherapy for metastatic or unresectable, locally advanced colorectal cancer, with no limit on the number of prior regimens. Patients who develop recurrent or metastatic disease on or within 6 months of adjuvant therapy are eligible.
  • Age \>/=18 years to provide a uniform oncologic phenotype of adult-onset colorectal cancer.
  • ECOG performance status 0-2.
  • The patient has signed informed consent.

You may not qualify if:

  • \) Inability to comply with study and/or follow-up procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Overman MJ, Morris V, Kee B, Fogelman D, Xiao L, Eng C, Dasari A, Shroff R, Mazard T, Shaw K, Vilar E, Raghav K, Shureiqi I, Liang L, Mills GB, Wolff RA, Hamilton S, Meric-Bernstam F, Abbruzzese J, Morris J, Maru D, Kopetz S. Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials. Ann Oncol. 2016 Jun;27(6):1068-1074. doi: 10.1093/annonc/mdw073. Epub 2016 Feb 18.

    PMID: 27045102DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood (16 mL) collected and archived tumor samples (primary tumor or metastatic site) from prior surgeries or biopsies.

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Scott Kopetz, MD

    M.D. Anderson Cancer 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

September 3, 2010

First Posted

September 8, 2010

Study Start

August 1, 2010

Primary Completion

December 9, 2022

Study Completion

December 9, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations

US(1)