Screening Trial to Study Eligibility of Patients to Participate in Head and Neck Surgery Clinical Trials - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2002

Last Updated Date

July 7, 2009

Start Date ^ICMJE

June 2002

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patient eligibility during screening [ Designated as safety issue: No ]
Permission of standard treatment in patients ineligible for a Head and Neck Surgery Branch (HNSB) protocol as assessed by clinical exam and imaging studies during screening [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Patient eligibility during screening
Permission of standard treatment in patients ineligible for a Head and Neck Surgery Branch (HNSB) protocol as assessed by clinical exam and imaging studies during screening

Change History

Complete list of historical versions of study NCT00045071 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Screening Trial to Study Eligibility of Patients to Participate in Head and Neck Surgery Clinical Trials

Official Title ^ICMJE

Evaluation For NIDCD Head And Neck Surgery Branch Clinical Research Protocols

Brief Summary

RATIONALE: Evaluating patients for eligibility in clinical trials may help doctors plan more effective surgery for patients who have cancer.

PURPOSE: This screening trial is determining the eligibility of patients to participate in head and neck surgery clinical trials at the National Institute on Deafness and Other Communication Disorders and National Cancer Institute.

Detailed Description

OBJECTIVES:

Evaluate eligibility of patients with neoplastic disease of the head and neck for clinical research protocols at the National Institute on Deafness and Other Communication Disorders Head and Neck Surgery Branch and National Cancer Institute.

OUTLINE: Patients undergo various diagnostic procedures and clinical testing to determine protocol eligibility. The procedures and testing may include, but are not limited to, laboratory blood tests, including HLA typing, hepatitis screening, and HIV serology; various nuclear medicine and imaging scans with or without contrast dye; pulmonary function tests; endoscopy; incisional or excisional biopsy; fine-needle aspiration; and arteriogram.

PROJECTED ACCRUAL: A maximum of 300 patients will be accrued for this study within 5 years.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Screening, Non-Randomized, Active Control

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Other: physiologic testing

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Completion Date

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed or suspected neoplastic disease of the head and neck with 1 of the following histological subtypes:
- Squamous cell carcinoma
- Verrucous carcinoma

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Concurrent chemotherapy allowed

Endocrine therapy

Not specified

Radiotherapy

Concurrent radiotherapy allowed

Surgery

No concurrent surgical procedure except those required by a screening test or biopsy on this study

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00045071

Responsible Party

Study ID Numbers ^ICMJE

CDR0000256310, NCI-01-DC-0099

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Carter Van Waes, MD, PhD

National Institute on Deafness and Other Communication Disorders (NIDCD)

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP