Gene Polymorphisms and Symptoms in Lung Cancer Patients
Primary Objectives:
- Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up.
- Develop preliminary statistical models incorporating genetic data (which will be obtained from an existing protocol, CPN 91-001, Margaret Spitz), disease-related variables (e.g., stage of disease, location of tumor), clinical health status (e.g., performance status, comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race) for predicting the risk of severe and persistent symptoms.
Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).
This study (NIH-CA109043, Reyes-Gibby, 2004-2009) builds upon an NIH-funded (NIH-CA55769, Spitz, 2003-2008) study of the molecular epidemiology of lung cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
If you agree to take part in this study, upon being admitted for treatment, you will be asked about your symptoms (how severe they are and to what degree they affect your day-to-day functioning).
You will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits. The questionnaire will take about 5 to 10 minutes to complete each time.
You may also be contacted at home so that researchers can follow-up on your experience with symptoms (only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits). If you are contacted by phone, the call should last about 5 to 10 minutes each time.
Researchers will also try to collect some of your leftover blood (that was already drawn and stored for research studies) from a previous lung cancer study (Ecogenetics of Lung Cancer) that you participated in at M. D. Anderson. Researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms. If you did not have blood collected in the previous lung cancer study, you will have a blood sample (one tablespoon) drawn when you first agree to participate in this study.
This is an investigational study. Up to 320 patients will take part in this study. All will be enrolled at M. D. Anderson.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
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Texas
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Houston, Texas, États-Unis, 77030
- University of Texas MD Anderson Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patient has lung cancer and is being treated at M. D. Anderson.
- At least 18 years of age
- Currently living in the United States
- Enrolled in CPN 91-001 (Molecular epidemiology of lung cancer)
- English or Spanish speaking
Exclusion Criteria:
- Patient is unable to understand the intent of the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Symptoms Questionnaire
Patients with lung cancer.
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Symptoms questionnaire lasting about 5 to 10 minutes.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Patient Symptom Severity (MD Anderson Symptom Inventory Questionnaire)
Délai: Baseline (before), during (every week for 6 weeks), and after chemoradiation therapy (at 6-12 week intervals)
|
Baseline (before), during (every week for 6 weeks), and after chemoradiation therapy (at 6-12 week intervals)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Cielito C. Reyes-Gibby, DrPH, M.D. Anderson Cancer Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2006-0273
- CA109043 (Autre subvention/numéro de financement: NCI)
Informations sur les médicaments et les dispositifs, documents d'étude
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