Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 9, 2009 | ||||
| Last Updated Date | July 21, 2010 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00898300 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer | ||||
| Official Title ICMJE | Establishment of a Head and Neck Cancer Tissue/Specimen Bank | ||||
| Brief Summary | RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with cancer to study in the laboratory may help the study of cancer in the future. PURPOSE: This laboratory study is collecting and storing tissue samples from patients with head and neck cancer. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: This is a prospective, multicenter study. Patients enrolled on active Radiation Therapy Oncology Group clinical trials undergo biopsy or surgical resection of head and neck tumors or premalignant lesions at participating institutions. Tissue and other specimens collected at the time of biopsy or surgery are submitted to the Head and Neck Cancer Tissue/Specimen Bank which acts as a central repository for processing, storing, and preserving patient specimens for translational research. Tissue samples include paraffin-embedded blocks or fresh or frozen samples of normal squamous mucosa, tumors, or premalignant lesions of the upper aerodigestive tract. Other specimens for tissue banking include serum, plasma, and lymphocytes isolated from peripheral blood, as well as samples of patient saliva. Cells obtained from tissue bank specimens may also be used to establish cell lines for future research. PROJECTED ACCRUAL: An unlimited number of specimens will be accrued for this study. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Head and Neck Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00898300 | ||||
| Other Study ID Numbers ICMJE | CDR0000460036, RTOG-0514 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Radiation Therapy Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||