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Collection and Storage of Blood and Tissue Samples From Patients Who Are Undergoing Surgery For Lung Cancer

2. august 2022 oppdatert av: Alliance for Clinical Trials in Oncology

The CALGB Lung Cancer Tissue Bank

This research studies collecting and storing tissue and blood samples from patients with lung cancer who are undergoing surgery. Collecting and storing samples of tissue and blood from patients with lung cancer to study in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  1. To collect, catalog and store frozen samples of lung carcinoma and when possible, portions of involved lymph nodes, as well as adjacent grossly uninvolved lung tissue obtained from surgical specimens of patients undergoing surgical resection for previously untreated lung cancer as a source of quality DNA, messenger ribonucleic acid (mRNA) and protein for molecular analysis.
  2. To collect, catalog and store frozen samples of blood pre- and post-resection from the same patients to provide a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung, and to allow assessment of levels of circulating markers.
  3. To associate these specimens with historical, clinical, pathological, and outcome information.

Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the Cancer and Leukemia Group B (CALGB) Lung Cancer Tissue Bank for future use in research. Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.

Studietype

Observasjonsmessig

Registrering (Forventet)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Delaware
      • Lewes, Delaware, Forente stater, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, Forente stater, 19713
        • CCOP - Christiana Care Health Services
    • Maryland
      • Elkton, Maryland, Forente stater, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Dana-Farber/Brigham and Women's Cancer Center
      • Boston, Massachusetts, Forente stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • Masonic Cancer Center at University of Minnesota
    • Missouri
      • Columbia, Missouri, Forente stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Saint Louis, Missouri, Forente stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • New Jersey
      • Voorhees, New Jersey, Forente stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Buffalo, New York, Forente stater, 14263-0001
        • Roswell Park Cancer Institute
      • Syracuse, New York, Forente stater, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28805
        • Veterans Affairs Medical Center - Asheville
      • Durham, North Carolina, Forente stater, 27710
        • Duke Cancer Institute
    • Pennsylvania
      • Monroeville, Pennsylvania, Forente stater, 15146
        • Forbes Regional Hospital
      • Natrona Heights, Pennsylvania, Forente stater, 15065
        • Alle-Kiski Medical Center
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • Miriam Hospital
      • Providence, Rhode Island, Forente stater, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection at a CALGB Lung Cancer Tissue Bank-approved institution.

Beskrivelse

  1. Histologic Documentation: All patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection are eligible whether or not the patient participates in a CALGB-sponsored treatment trial; patients enrolled on a CALGB trial of preoperative chemotherapy for lung cancer will be eligible if a pre-treatment frozen sample of tumor (e.g., a positive lymph node from mediastinoscopy) can be submitted to the bank; patients enrolled on CALGB 140203, intraoperative sentinel node mapping in non-small cell lung cancer, are not eligible.
  2. No patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Bare etui
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Ancillary-Correlative (lung cancer tissue bank)
Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the CALGB Lung Cancer Tissue Bank for future use in research. Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.
Annen: cytology specimen collection procedure
correlative studies
Andre navn:
  • cytologisk prøvetaking

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Collection and storage of frozen tissue samples for molecular analysisor resection of lung cancer
Tidsramme: Up to 5 years
Up to 5 years
Collection and storage of frozen blood samples for the assessment of somatic mutations and levels of circulating markersto assess levels of circulating markers
Tidsramme: Up to 5 years
Up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: William Richards, MD, Brigham and Women's Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juli 2004

Primær fullføring (Faktiske)

1. januar 2022

Studiet fullført (Faktiske)

15. februar 2022

Datoer for studieregistrering

Først innsendt

9. mai 2009

Først innsendt som oppfylte QC-kriteriene

9. mai 2009

Først lagt ut (Anslag)

12. mai 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2022

Sist bekreftet

1. august 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CALGB-140202
  • U10CA180821 (U.S. NIH-stipend/kontrakt)
  • U10CA031946 (U.S. NIH-stipend/kontrakt)
  • CDR0000271323 (Registeridentifikator: NCI Physician Data Query)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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