NCT00001603

Brief Summary

The goal of this study is to learn how tumors of the upper airway and digestive passages (tongue, throat, mouth, and voicebox) affect the body's immune defenses and energy storage. Previous studies have shown that tumors of the vocal tract produce signals that could help the tumor escape the body's immune defenses and use the body's energy and mineral stores to grow. Researchers are hoping to learn more about what signals give tumor cells an advantage to live and grow, how tumor cells control these signals, and how these signals affect the rest of the body. This study will look closer at researchers belief that tumors in the vocal tract contain genes (genetic information) that abnormally function to allow the tumors to survive and grow against the attack of the body's normal immune system Patients with cancerous tumors (squamous cell carcinoma) and benign (non-cancerous) tumors (papilloma) of the upper aerodigestive tract who are candidates for standard or investigational therapy are eligible to participate in this study. Tumor cells will be collected from patients participating in the study, who will undergo standard surgical treatment or biopsies for their conditions. Once tumor cells are collected they can be analyzed for their genetic make-up. In addition, patients will undergo several tests using skin, blood, and urine to look closely at the function of their immune systems and metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 1996

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

December 1, 1996

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 2004

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Esophageal NeoplasmHead and Neck NeoplasmLaryngeal NeoplasmPapillomaSquamous Cell Carcinoma

Keywords

CytokinesSquamous Cell CarcinomaPapillomaCommunicationImmunityHeadNeckHead and Neck Cancer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven squamous cell carcinoma or papilloma.
  • Age greater than 18.
  • No immunodeficiency (congenital or acquired).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Deafness and Other Communication Disorders (NIDCD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Wang MB, Lichtenstein A, Mickel RA. Hierarchical immunosuppression of regional lymph nodes in patients with head and neck squamous cell carcinoma. Otolaryngol Head Neck Surg. 1991 Oct;105(4):517-27. doi: 10.1177/019459989110500403.

    PMID: 1762790BACKGROUND

  • Sato K, Mimura H, Han DC, Kakiuchi T, Ueyama Y, Ohkawa H, Okabe T, Kondo Y, Ohsawa N, Tsushima T, et al. Production of bone-resorbing activity and colony-stimulating activity in vivo and in vitro by a human squamous cell carcinoma associated with hypercalcemia and leukocytosis. J Clin Invest. 1986 Jul;78(1):145-54. doi: 10.1172/JCI112544.

    PMID: 3487554BACKGROUND

  • Gallo O, Gori AM, Attanasio M, Martini F, Giusti B, Brunelli T, Gallina E. Interleukin-6 and acute-phase proteins in head and neck cancer. Eur Arch Otorhinolaryngol. 1995;252(3):159-62. doi: 10.1007/BF00178104.

    PMID: 7544987BACKGROUND

MeSH Terms

Conditions

Esophageal NeoplasmsHead and Neck NeoplasmsLaryngeal NeoplasmsPapillomaCarcinoma, Squamous CellCommunication

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesOtorhinolaryngologic NeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic DiseasesNeoplasms, Squamous CellNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinomaBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

December 1, 1996

Study Completion

December 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-12

Locations

US(1)