- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Genetisch: Polymorphismusanalyse
- Sonstiges: Konservierungsverfahren für biologische Proben
- Sonstiges: Überprüfung der Krankenakte
- Genetisch: Mutationsanalyse
- Sonstiges: Fragebogenverwaltung
- Verfahren: Bewertung von Krebsrisikofaktoren
- Genetisch: Verlust der Heterozygotieanalyse
- Genetisch: Polymerase Kettenreaktion
- Genetisch: genetische Kopplungsanalyse
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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England
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Sheffield, England, Vereinigtes Königreich, S1O 2SJ
- Rekrutierung
- Cancer Research Centre at Weston Park Hospital
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Kontakt:
- Penella J. Woll, MD, PhD
- Telefonnummer: 44-114-226-5206
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
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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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Penella J. Woll, MD, PhD, Cancer Research Centre at Weston Park Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- rezidivierender nicht-kleinzelliger Lungenkrebs
- kleinzelliger Lungenkrebs im fortgeschrittenen Stadium
- rezidivierender kleinzelliger Lungenkrebs
- nicht-kleinzelliger Lungenkrebs im Stadium IIIA
- nicht-kleinzelliger Lungenkrebs im Stadium IIIB
- nicht-kleinzelliger Lungenkrebs im Stadium IV
- nicht-kleinzelliger Lungenkrebs im Stadium I
- nicht-kleinzelliger Lungenkrebs im Stadium II
- Kleinzelliger Lungenkrebs im begrenzten Stadium
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CRC-WPH-USMS-ReSoLuCENT
- CDR0000589308 (Registrierungskennung: PDQ (Physician Data Query))
- EU-20826
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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