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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00899782
Collaborator
National Cancer Institute (NCI) (NIH)
500
19
211.1
26.3
0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cytology specimen collection procedure

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The CALGB Lung Cancer Tissue Bank
Actual Study Start Date :
Jul 15, 2004
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Feb 15, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Other: cytology specimen collection procedure
correlative studies
Other Names:
  • cytologic sampling
  • Outcome Measures

    Primary Outcome Measures

    1. Collection and storage of frozen tissue samples for molecular analysisor resection of lung cancer [Up to 5 years]

    2. Collection and storage of frozen blood samples for the assessment of somatic mutations and levels of circulating markersto assess levels of circulating markers [Up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tunnell Cancer Center at Beebe Medical Center Lewes Delaware United States 19958
    2 CCOP - Christiana Care Health Services Newark Delaware United States 19713
    3 Union Hospital of Cecil County Elkton Maryland United States 21921
    4 Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts United States 02115
    5 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    6 Masonic Cancer Center at University of Minnesota Minneapolis Minnesota United States 55455
    7 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
    8 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri United States 63110
    9 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
    10 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    11 SUNY Upstate Medical University Hospital Syracuse New York United States 13210
    12 Veterans Affairs Medical Center - Asheville Asheville North Carolina United States 28805
    13 Duke Cancer Institute Durham North Carolina United States 27710
    14 Forbes Regional Hospital Monroeville Pennsylvania United States 15146
    15 Alle-Kiski Medical Center Natrona Heights Pennsylvania United States 15065
    16 Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    17 Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island United States 02903
    18 Miriam Hospital Providence Rhode Island United States 02906
    19 Fletcher Allen Health Care - University Health Center Campus Burlington Vermont United States 05401

    Sponsors and Collaborators

    • Alliance for Clinical Trials in Oncology
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alliance for Clinical Trials in Oncology
    ClinicalTrials.gov Identifier:
    NCT00899782
    Other Study ID Numbers:
    • CALGB-140202
    • CALGB-140202
    • CDR0000271323
    • U10CA031946
    • U10CA180821
    First Posted:
    May 12, 2009
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022