Esophageal NeoplasmNCT00001603
The Effects of Upper Airway and Digestive Tract Tumors on the Immune System
An observational study of Esophageal Neoplasm and Head and Neck Neoplasm, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Esophageal Neoplasm, Head and Neck Neoplasm, Laryngeal Neoplasm
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1996to Dec 2004
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Biopsy proven squamous cell carcinoma or papilloma.
- Age greater than 18.
- No immunodeficiency (congenital or acquired).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Deafness and Other Communication Disorders (NIDCD)
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of Immunoregulatory Factor Expression and Immune Responses in Patients With Squamous Cell Carcinoma or Papilloma of the Upper Aerodigestive Tract
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.
Read more
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.
Read the detailed description
Patients with squamous cell carcinoma or papilloma of the upper aerodigestive tract who are candidates for standard or investigational therapy are eligible to participate in this pilot immunopathogenesis study. Patients with these neoplasms exhibit alterations in immune and metabolic regulation. These alterations in immunoregulation have been shown to affect prognosis, and have thus far been an obstacle to the successful development of active immunization and cytokine immunotherapy that have been attempted in order to improve preservation of organ function and survival. This is a pilot study to explore the basis for alterations in immune and metabolic regulation in patients with these tumors. Similar alterations in immunity and metabolism usually occur in response to injury and infection, and are mediated by expression of immunoregulatory signals. The study will evaluate the hypothesis that regulatory and structural genes involved in immunoregulation are abnormally expressed within the tumor and that these signals can promote tumor development and progression by conferring a selective growth or survival advantage. The expression and activity of immunoregulatory genes and signals which are expressed by neoplastic or non-neoplastic cells within the tumor will be analyzed using tumor cells and leukocytes derived from patient specimens obtained during clinically indicated biopsies or surgical therapy. Tumor and keratinocyte cell lines will be established for analysis of differential gene and cytokine expression of neoplastic cells, and lymphocyte cell lines will be established to test culture and signal conditions for stimulating regulatory and effector immune responses of patient lymphocytes in vitro. The potential of factors identified to promote altered immune and metabolic function will be evaluated in the patients by skin, blood and urine immune and metabolic assays performed before and after tumor resection or cytoreduction. Patients participating in these investigations would be expected to benefit from receipt of standard therapy and would encumber minimal additional risk beyond those procedures for the standard or investigational therapy for which the patient will be asked to consent. Twenty patients each with squamous cell carcinoma and papilloma will be accepted to undergo standard therapy under this protocol, and twenty patients may be accepted for study while undergoing therapy on other approved investigational protocol(s). Twenty age-matched clinical research volunteers will be evaluated as control subjects for the skin, blood and urine tests.
- Conditions
- Esophageal Neoplasm, Head and Neck Neoplasm, Laryngeal Neoplasm, Papilloma, Squamous Cell Carcinoma
- Keywords
- Cytokines, Squamous Cell Carcinoma, Papilloma, Communication, Immunity, Head, Neck, Head and Neck Cancer
- Medical subject headings
- Esophageal Neoplasms, Head and Neck Neoplasms, Laryngeal Neoplasms, Papilloma, Carcinoma, Squamous Cell, Communication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startDec 1996
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- 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
- Enrolment
- 93 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001603
- Sponsor's protocol ID
- 970044
- Other IDs
- 97-DC-0044
- Status last verified
- Dec 2004
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 1762790Sato 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.
PubMed 3487554Gallo 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.
PubMed 7544987
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Immunoregulatory Factor Expression and Immune Responses in Patients With Squamous Cell Carcinoma or Papilloma of the Upper Aerodigestive Tract
- ClinicalTrials.gov ID
- NCT00001603
- Acronym / sponsor ID
- 970044
- Conditions
- Esophageal Neoplasm, Head and Neck Neoplasm, Laryngeal Neoplasm, Papilloma, Squamous Cell Carcinoma
- Keywords
- Cytokines, Squamous Cell Carcinoma, Papilloma, Communication, Immunity, Head, Neck, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- Dec 1996
- Study completion
- Dec 2004
- First posted
- 4 Nov 1999 (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 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.
Detailed description
Patients with squamous cell carcinoma or papilloma of the upper aerodigestive tract who are candidates for standard or investigational therapy are eligible to participate in this pilot immunopathogenesis study. Patients with these neoplasms exhibit alterations in immune and metabolic regulation. These alterations in immunoregulation have been shown to affect prognosis, and have thus far been an obstacle to the successful development of active immunization and cytokine immunotherapy that have been attempted in order to improve preservation of organ function and survival. This is a pilot study to explore the basis for alterations in immune and metabolic regulation in patients with these tumors. Similar alterations in immunity and metabolism usually occur in response to injury and infection, and are mediated by expression of immunoregulatory signals. The study will evaluate the hypothesis that regulatory and structural genes involved in immunoregulation are abnormally expressed within the tumor and that these signals can promote tumor development and progression by conferring a selective growth or survival advantage. The expression and activity of immunoregulatory genes and signals which are expressed by neoplastic or non-neoplastic cells within the tumor will be analyzed using tumor cells and leukocytes derived from patient specimens obtained during clinically indicated biopsies or surgical therapy. Tumor and keratinocyte cell lines will be established for analysis of differential gene and cytokine expression of neoplastic cells, and lymphocyte cell lines will be established to test culture and signal conditions for stimulating regulatory and effector immune responses of patient lymphocytes in vitro. The potential of factors identified to promote altered immune and metabolic function will be evaluated in the patients by skin, blood and urine immune and metabolic assays performed before and after tumor resection or cytoreduction. Patients participating in these investigations would be expected to benefit from receipt of standard therapy and would encumber minimal additional risk beyond those procedures for the standard or investigational therapy for which the patient will be asked to consent. Twenty patients each with squamous cell carcinoma and papilloma will be accepted to undergo standard therapy under this protocol, and twenty patients may be accepted for study while undergoing therapy on other approved investigational protocol(s). Twenty age-matched clinical research volunteers will be evaluated as control subjects for the skin, blood and urine tests.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy proven squamous cell carcinoma or papilloma.
- Age greater than 18.
- No immunodeficiency (congenital or acquired).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 1762790Wang 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.
- Background: PubMed 3487554Sato 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.
- Background: PubMed 7544987Gallo 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Esophageal Neoplasm and Head and Neck Neoplasm, run by National Institute on Deafness and Other Communication Disorders (NIDCD) 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 0 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 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001603, which also lists 3 linked publications.
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 4 Mar 2008.