- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00693836
Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
Resource for the Study of Lung Cancer Epidemiology in North Trent
RATIONALE: Gathering information about genetic and environmental factors from patients with lung cancer and their partners and first-degree relatives may help doctors learn more about the disease.
PURPOSE: This clinical trial is looking at the patterns, causes, and control of disease in patients with lung cancer in the North Trent (England) region.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Génétique: analyse de polymorphisme
- Autre: procédure de conservation des échantillons biologiques
- Autre: examen du dossier médical
- Génétique: analyse des mutations
- Autre: gestion des questionnaires
- Procédure: évaluation des facteurs de risque de cancer
- Génétique: analyse de la perte d'hétérozygotie
- Génétique: réaction en chaîne par polymérase
- Génétique: analyse de liaison génétique
Description détaillée
OBJECTIVES:
Primary
- To establish a resource bank of high quality genomic and plasma DNA and tumor and serum samples linked to clinical data obtained from detailed family history and lifestyle questionnaires from patients with lung cancer and from their partners and first-degree relatives for genetic epidemiology studies of lung cancer.
Secondary
- To study single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples from patients with lung cancer and from their partners and first-degree relatives.
- To study genetic changes of lung cancer in plasma DNA samples from patients with lung cancer and from their partners and first-degree relatives.
OUTLINE: This is a multicenter study.
Patients and their partners complete a detailed, interview-based questionnaire to assess their environmental risk factors for cancer. Information on past medical, social, occupational, and smoking history as well as family history, including any malignancies diagnosed and subsequent causes of death, is collected. First-degree relatives of patients complete an interview-based questionnaire about smoking, occupational, and cancer history. Relatives of patients' partners complete a telephone-administered questionnaire only.
Medical records of patients are reviewed to obtain information on pathological diagnosis and laboratory number, date of diagnosis, stage of disease, performance status, co-morbidities, and treatment plan. Medical records of partners may also be reviewed to obtain information on the incidence of smoking-related malignancies (i.e., cancer of the lung, larynx, esophagus, stomach, bladder, or head and neck).
Patients and their partners and first-degree relatives undergo blood sample collection for laboratory studies. Previously collected tumor samples are obtained from patients. Plasma DNA, lymphocyte DNA, and tumor DNA are analyzed by polymerase chain reaction (PCR) to identify loss of heterozygosity (LOH) between genomic (lymphocyte) DNA and the tumor and plasma DNA. Specific tumor-associated mutations are also analyzed by real-time PCR. Single nucleotide polymorphism studies, including common gene polymorphisms (metabolic genes, DNA repair genes, and tumor suppressor genes), in lung cancer families are also conducted.
A statistical model will be developed for future analysis and will include correlations in genetic alterations in DNA isolated from tumor and plasma, familial aggregation studies, and genetic analysis studies.
PROJECTED ACCRUAL: A total of 2,000 participants (500 patients and 1,500 partners and first-degree relatives [controls]) will be accrued for this study.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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England
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Sheffield, England, Royaume-Uni, S1O 2SJ
- Recrutement
- Cancer Research Centre at Weston Park Hospital
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Contact:
- Penella J. Woll, MD, PhD
- Numéro de téléphone: 44-114-226-5206
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Patient meeting the following criteria:
- Pathologically confirmed lung cancer or planning to undergo lung cancer surgery pending pathological confirmation
- Evidence of active disease (i.e., not in remission)
Meets 1 of the following criteria:
- 60 years of age and under
- Has a first-degree relative with lung cancer who is 60 years of age and under
- Has two or more first- or second-degree relatives with lung cancer at any age
Control meeting the following criteria:
- Co-habiting partner of patient OR first-degree relative of patient or their partner
- 18 years of age and over
- Resides within the North Trent Cancer Network region
PATIENT CHARACTERISTICS:
- Able and willing to complete study procedures
PRIOR CONCURRENT THERAPY:
- Not specified
Plan d'étude
Comment l'étude est-elle conçue ?
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples
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Mesures de résultats secondaires
Mesure des résultats |
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Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples
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Genetic changes of lung cancer in plasma DNA samples
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Penella J. Woll, MD, PhD, Cancer Research Centre at Weston Park Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- cancer bronchique non à petites cellules récurrent
- cancer du poumon à petites cellules au stade étendu
- cancer du poumon à petites cellules récurrent
- cancer du poumon non à petites cellules de stade IIIA
- cancer du poumon non à petites cellules de stade IIIB
- cancer du poumon non à petites cellules de stade IV
- cancer du poumon non à petites cellules de stade I
- cancer du poumon non à petites cellules de stade II
- cancer du poumon à petites cellules de stade limité
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRC-WPH-USMS-ReSoLuCENT
- CDR0000589308 (Identificateur de registre: PDQ (Physician Data Query))
- EU-20826
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