NCT01487733

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

December 22, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2012

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

December 6, 2011

Last Update Submit

May 16, 2017

Conditions

Keywords

metastatic squamous neck cancer with occult primary squamous cell carcinomametastatic squamous neck cancer with occult primaryrecurrent 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 nasopharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitysalivary gland squamous cell carcinomastage 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 nasopharynxstage 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 cavityrecurrent salivary gland cancerstage III salivary gland cancerstage IVA salivary gland cancerstage IVB salivary gland cancerstage IVC salivary gland cancer

Outcome Measures

Primary Outcomes (1)

  • Treatment response

    1 year

Interventions

Eligibility Criteria

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

Samples from patients who participated in E1395 or E3301 and provided samples for research.

DISEASE CHARACTERISTICS: * Tissue specimens from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301 * Stage III, IV, or recurrent disease * Squamous cell disease * Any of the following diagnoses: * Lip and oral cavity * Oropharynx * Hypopharynx * Larynx * Paranasal sinus and nasal cavity * Squamous neck cancer * Salivary gland 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

Related Publications (1)

  • Argiris A, Li S, Ghebremichael M, Egloff AM, Wang L, Forastiere AA, Burtness B, Mehra R. Prognostic significance of human papillomavirus in recurrent or metastatic head and neck cancer: an analysis of Eastern Cooperative Oncology Group trials. Ann Oncol. 2014 Jul;25(7):1410-1416. doi: 10.1093/annonc/mdu167. Epub 2014 May 5.

MeSH Terms

Conditions

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

Interventions

Gene Expression ProfilingIn Situ HybridizationImmunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesNucleic Acid HybridizationHistocytochemistryImmunologic Techniques

Study Officials

  • Athanassios Argiris, MD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 7, 2011

Study Start

December 22, 2011

Primary Completion

January 22, 2012

Study Completion

January 22, 2012

Last Updated

May 17, 2017

Record last verified: 2017-05