NCT01080313

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 1, 2005

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

6.3 years

First QC Date

March 2, 2010

Last Update Submit

February 10, 2012

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Patterns of care for head and neck cancer

    up to 10 years

Secondary Outcomes (4)

  • 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

  • Identify supportive care received for managing nutrition, pain, nausea and other complications

    up to 10 years

  • tumor control by treatment regimen

    study entry to progressive disease

Study Arms (1)

Patients with head and neck cancer

Other: Therapy for head and neck cancer

Interventions

Therapy for head and neck cancerOTHER

radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy

Patients with head and neck cancer

Eligibility Criteria

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

Primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mednet Solutions

Minnetonka, Minnesota, 55305, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Mednet Solutions

    MedNet Solutions

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 4, 2010

Study Start

August 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

US(1)