Head and Neck CancerLORHANNCT01080313
Head and Neck Cancer Registry (LORHAN)
An observational study of Head and Neck Cancer, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Therapy for head and neck cancer
- How many people
- 26,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy Other Than Surgical Resection Alone for Newly Diagnosed Head and Neck Cancer
The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient
- Conditions
- Head and Neck Cancer
- Being tested
- Therapy for head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy for head and neck cancerOther
radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with head and neck cancer | Not described Receives: Other: Therapy for head and neck cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns of care for head and neck cancer
Measured: up to 10 years
Secondary outcomes (4)
Overall survival by treatment regimen
Measured: 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
Measured: up to 10 years
Identify supportive care received for managing nutrition, pain, nausea and other complications
Measured: up to 10 years
tumor control by treatment regimen
Measured: study entry to progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startAug 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 26,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mednet Solutions, Study director, MedNet Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080313
- Sponsor's protocol ID
- 13440
- Other IDs
- I4E-US-S003
- Acronym
- LORHAN
- Status last verified
- Feb 2012
- First submitted
- 2 Mar 2010
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy Other Than Surgical Resection Alone for Newly Diagnosed Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01080313
- Acronym / sponsor ID
- LORHAN / 13440
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,000 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with head and neck cancer | – | Other: Therapy for head and neck cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy for head and neck cancerradiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy | Other | Patients with head and neck cancer |
Primary outcome
Patterns of care for head and neck cancer
Time frame: up to 10 years
4 secondary outcomes
Overall survival by treatment regimen
Time frame: 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
Time frame: up to 10 years
Identify supportive care received for managing nutrition, pain, nausea and other complications
Time frame: up to 10 years
tumor control by treatment regimen
Time frame: study entry to progressive disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
Related trials for Head and Neck Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
Active, not recruitingPhase 2
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
Head and Neck Cancer
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mednet Solutions study director
MedNet Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of care for head and neck cancer (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2012.