NCT00898911

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2012

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

3.8 years

First QC Date

May 9, 2009

Last Update Submit

May 16, 2017

Conditions

Keywords

recurrent squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent verrucous carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavitymetastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent metastatic squamous neck cancer with occult primaryrecurrent squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent salivary gland cancersalivary gland squamous cell carcinomastage IV salivary gland cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival measured in weeks

    1 month

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients enrolled on E3301

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Christine Chung, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

July 8, 2008

Primary Completion

April 8, 2012

Study Completion

April 8, 2012

Last Updated

May 17, 2017

Record last verified: 2017-05