We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Head and Neck Cancer Registry (LORHAN) (LORHAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01080313
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : February 13, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Head and Neck Cancer Other: Therapy for head and neck cancer

Study Design

Study Type : Observational
Estimated Enrollment : 26000 participants
Time Perspective: Prospective
Official Title: Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy Other Than Surgical Resection Alone for Newly Diagnosed Head and Neck Cancer
Study Start Date : August 2005
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients with head and neck cancer Other: Therapy for head and neck cancer
radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy


Outcome Measures

Primary Outcome Measures :
  1. Patterns of care for head and neck cancer [ Time Frame: up to 10 years ]

Secondary Outcome Measures :
  1. Overall survival by treatment regimen [ Time Frame: study entry to death from any cause or to end of study ]
  2. Determine the incidence and severity of major dose-limiting and other important treatment toxicities [ Time Frame: up to 10 years ]
  3. Identify supportive care received for managing nutrition, pain, nausea and other complications [ Time Frame: up to 10 years ]
  4. tumor control by treatment regimen [ Time Frame: study entry to progressive disease ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080313


Locations
United States, Minnesota
Mednet Solutions
Minnetonka, Minnesota, United States, 55305
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Mednet Solutions MedNet Solutions
More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01080313     History of Changes
Other Study ID Numbers: 13440
I4E-US-S003 ( Other Identifier: Eli Lilly and Company )
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms