Blood Sample Analysis in Predicting Overall Survival in Patients With Recurrent or Metastatic Head and Neck Cancer

NCT ID: NCT00898911

Last Updated: 2017-05-17

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

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-08

Study Completion Date

2012-04-08

Brief Summary

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RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood sample analysis in predicting overall survival in patients with recurrent or metastatic head and neck cancer.

Detailed Description

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OBJECTIVES:

* To validate the mass spectrometry profile that is predictive of survival benefit in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with EGFR inhibitors.

OUTLINE: Plasma and serum samples are analyzed by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and classified according to prognosis ("good" vs "poor") using a previously developed predictive algorithm.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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matrix-assisted laser desorption/ionization time of flight mass spectrometry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma
* Meets 1 of the following criteria:

* Enrolled on clinical trial ECOG-E3301 and previously treated with irinotecan hydrochloride and docetaxel
* Enrolled on clinical trial VU-VICC-HN-0501 and previously treated with docetaxel and bortezomib
* Plasma and serum samples available for analysis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Chung, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Other Identifiers

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ECOG-E3301T1

Identifier Type: -

Identifier Source: secondary_id

CDR0000600560

Identifier Type: -

Identifier Source: org_study_id

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