NCT01192750

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with cisplatin with or without cetuximab.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

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

Study Start

First participant enrolled

August 5, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2010

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

August 31, 2010

Last Update Submit

May 16, 2017

Conditions

Keywords

recurrent 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 cavitystage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent verrucous carcinoma of the larynxrecurrent verrucous carcinoma of the oral cavitystage IV verrucous carcinoma of the larynxstage IV verrucous carcinoma of the oral cavityrecurrent salivary gland cancersalivary gland squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Association between ERCC1 expression (low or high) with clinical outcomes

    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 from patients enrolled on E5397 from whom samples were submitted for research

DISEASE CHARACTERISTICS: * Diagnosis of squamous cell carcinoma of the head and neck * Recurrent and/or metastatic disease * Received cisplatin with or without cetuximab on clinical trial ECOG-E5397 * Slides and blocks of tumor specimens available 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

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • Ranee Mehra, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 1, 2010

Study Start

August 5, 2010

Primary Completion

October 5, 2010

Study Completion

October 5, 2010

Last Updated

May 17, 2017

Record last verified: 2017-05