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Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

NCT ID: NCT00467129

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-07-31

Brief Summary

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RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.

PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer.

Detailed Description

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OBJECTIVES:

* Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer.
* Collect detailed clinical, pathological, and chemotherapy data from these patients.
* Identify genetic factors that relate to treatment response and outcome in these patients.

OUTLINE: Blood samples are collected and relevant genes and regions are amplified by PCR. PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms. Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes.

Clinical and family history data is also collected by questionnaire.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Conditions

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Colorectal Cancer

Keywords

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stage IV colon cancer stage IV rectal cancer

Interventions

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microarray analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of metastatic colorectal cancer
* Currently receiving chemotherapy at Weston Park Hospital

PATIENT CHARACTERISTICS:

* Not Specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sheffield

OTHER

Sponsor Role lead

Principal Investigators

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Angela Cox, PhD

Role: STUDY_CHAIR

University of Sheffield

Other Identifiers

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SHEFF-SSREC01/271

Identifier Type: -

Identifier Source: secondary_id

SHEFF-USMS-SSREC01/271

Identifier Type: -

Identifier Source: secondary_id

EU-20727

Identifier Type: -

Identifier Source: secondary_id

CDR0000540670

Identifier Type: -

Identifier Source: org_study_id