Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients

NCT00502502 | Completed

• 1 other identifier: ANS02-495
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To determine the feasibility of a study that would describe changes of certain circulating inflammatory cytokines (interleukin-1, 6, 8, 10, 12, and tumor necrosis factor-alpha \[TNF\] and symptoms related to chemoradiation therapy (pre-therapy, during therapy and up to 3 months post-therapy) among patients with lung, esophageal, gastric, colorectal and anal cancer.
• To determine the feasibility of studying neurocognitive function in patients with non-small cell lung cancer (NSCLC) at presentation and during chemoradiation therapy to determine the prevalence, severity, and pattern of cognitive symptoms.

Conditions

Anal Cancer; Colorectal Cancer; Esophageal Cancer; Gastric Cancer; Lung Cancer

Keywords

Anal Cancer; Colorectal Cancer; Esophageal Cancer; Gastric Cancer; Lung Cancer; Questionnaire; Survey; Chemoradiation Therapy; Symptoms; Cytokines

Outcome Measures

Primary Outcomes (1)

• Patient Symptom Assessment (Questionnaire)

  Weekly for 1-3 months post-therapy

Study Arms (1)

Symptom-Related Cytokines Questionnaire

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Weekly questionnaires lasting about 30 minutes.

Also known as: Survey

Symptom-Related Cytokines Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants with lung, esophageal, gastric, colorectal or anal cancer.

You may qualify if:

• Patients scheduled for chemoradiation therapy at MDACC.
• Adults \> 18 years of age.
• Diagnosis of lung, esophageal, gastric, colorectal, or anal cancer.
• English-speaking.
• Lives in the United States.
• Adequate vision and hearing to use the IVR system.
• Provides written informed consent.

You may not qualify if:

• Patients with a current diagnosis of psychosis or dementia.
• Patients who are unable to complete the assessment measures or refuse to participate.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected to study the levels of cytokines in your blood.

MeSH Terms

Conditions

Anus Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Lung Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Colonic Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Xin Shelley Wang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 17, 2007
• Study Start: November 1, 2002
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

US (1)