Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00422500 · ClinicalTrials.gov registry record
Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 204
- Enrollment target
NCT00422500: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT00422500 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 204 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00422500 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 204 participants
- Enrollment target
Study Summary
Primary Objectives: * To compare the severity of symptoms, their impact on affective and health-related functional status, and symptom interference among patients with advanced-stage lung cancer following initiation of chemotherapy by disease status, tumor response to chemotherapy, and adequacy of symptom management. * To examine the relationship of disease-related and treatment-related physical symptoms to affective impairment and the patient's reported symptom interference and functional impairment. * To compare symptom severity, adequacy of symptom management, and interference with affective status and health-related function by patient's minority status. * To explore the serum level of inflammatory cytokines during chemotherapy among lung cancer patients. * To measure DNA repair capacity (DRC) in lymphocyte cultures of all patients enrolled in the protocol at baseline (before treatment) and during each follow-up blood draw. The hypothesis is that patients with suboptimal DRC will do better with chemotherapy than patients with efficient DRC. * To extract DNA and genotype for polymorphisms in genes involved in the nucleotide excision repair pathway and in those involved in response to pain (opioid receptors, dopamine receptors, COMT). We hypothesize that: 1. Polymorphisms in NER genes that modulate DNA repair capacity will also effect response to chemotherapy and to outcome. 2. Cytokine gene polymorphisms account for variations in symptom outcomes (specific symptoms and symptom clusters) before, during and after chemotherapy. 3. The COMT val/met polymorphism affects the metabolism of catecholamines on the modulation of response to sustained pain. 4. Dopamine receptor polymorphisms that result in decreased density of dopamine receptors will result in a deficit in the dopamine pathway. that will also affect response to pain. * To evaluate neurocognitive function to determine the prevalence, severity, and pattern of cognitive symptoms.
Interventions
- BEHAVIORAL Questionnaire
- OTHER Blood Samples
- BEHAVIORAL Telephone Interactive System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2003-11 |
| Est. Completion | 2010-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00422500
The ClinicalTrials.gov registry entry for NCT00422500 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Questionnaire is the first listed.
NCT00422500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00422500 about?
NCT00422500 is a clinical study titled "Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer". Primary Objectives: * To compare the severity of symptoms, their impact on affective and health-related functional status, and symptom interference among patients with advanced-stage lung cancer following initiation of chemotherapy by disease status, tumor response to chemotherapy, and adequacy of ...
What is the current status of trial NCT00422500?
This trial is currently completed. The enrollment target is 204 participants. The study started on 2003-11. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00422500?
The interventions under investigation include: Questionnaire (BEHAVIORAL), Blood Samples (OTHER), Telephone Interactive System (BEHAVIORAL).
Who is sponsoring clinical trial NCT00422500?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.