NCT01466257

Brief Summary

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

November 21, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

November 2, 2011

Last Update Submit

May 17, 2017

Conditions

Head and Neck Cancer

Keywords

metastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent metastatic squamous neck cancer with occult primaryrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the hypopharynxstage IVA squamous cell carcinoma of the larynxstage IVA squamous cell carcinoma of the lip and oral cavitystage IVA squamous cell carcinoma of the oropharynxstage IVA squamous cell carcinoma of the paranasal sinus and nasal cavitystage IVB squamous cell carcinoma of the larynxstage IVB squamous cell carcinoma of the lip and oral cavitystage IVB squamous cell carcinoma of the oropharynxstage IVB squamous cell carcinoma of the paranasal sinus and nasal cavitystage IVC squamous cell carcinoma of the larynxstage IVC squamous cell carcinoma of the lip and oral cavitystage IVC squamous cell carcinoma of the oropharynxstage IVC squamous cell carcinoma of the paranasal sinus and nasal cavityuntreated metastatic squamous neck cancer with occult primary

Outcome Measures

Primary Outcomes (1)

  • Mutation rates of HRAS and PIK3CA

    1 day

Interventions

cetuximabBIOLOGICAL
cisplatinDRUG
DNA analysisGENETIC
gene expression analysisGENETIC
mutation analysisGENETIC
laboratory biomarker analysisOTHER

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 participating in E5397

DISEASE CHARACTERISTICS: * Treated on protocol ECOG-E5397 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 Neck

Interventions

CetuximabCisplatinGene Expression Profiling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsGenetic TechniquesInvestigative Techniques

Study Officials

  • Christine H. Chung, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 7, 2011

Study Start

November 21, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 19, 2017

Record last verified: 2017-05