Head and Neck Cancer Registry (LORHAN) | NCT01080313

Studies
Head and Neck Cancer Registry (LORHAN)

NCT01080313

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Feb 13, 2012Estimated

Enrollment

26,000Estimated

Phase

Not provided

Conditions

Head and Neck Cancer

Interventions

Therapy for head and neck cancer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
I4E-US-S003	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 2, 2010

First Submission Date that Met QC Criteria

Mar 2, 2010

First Posted Date

Mar 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2012

Last Update Posted Date

Feb 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with head and neck cancer			Other: Therapy for head and neck cancer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therapy for head and neck cancer	Other	radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy	Patients with head and neck cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patterns of care for head and neck cancer		up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival by treatment regimen		study entry to death from any cause or to end of study
Determine the incidence and severity of major dose-limiting and other important treatment toxicities		up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically (histologically or cytologically) confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin
Scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy
Written informed consent

Exclusion Criteria:

Registry participation does not exclude participation in clinical trials.
Patients scheduled to receive or who have received surgery are eligible for Registry participation as long as they are also scheduled to receive medical therapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mednet Solutions	MedNet Solutions	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mednet Solutions		Minnetonka	Minnesota	55305	United States

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided