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

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ClinicalTrials.gov Identifier: NCT00899782
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date February 20, 2020
Study Start Date July 2004
Estimated Primary Completion Date January 2100   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 10, 2015)
  • Collection and storage of frozen tissue samples for molecular analysisor resection of lung cancer [ Time Frame: 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 [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • Collection and storage of frozen specimens of tumor, involved lymph node (when available), and grossly uninvolved adjacent lung tissues obtained from patients during surgical staging or resection of lung cancer
  • Collection and storage of frozen blood samples from these patients as a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung and to assess levels of circulating markers
  • Correlation of these analyses with historical, clinical, pathological, and outcome information
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection and Storage of Blood and Tissue Samples From Patients Who Are Undergoing Surgery For Lung Cancer
Official Title The CALGB Lung Cancer Tissue Bank
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor, blood
Sampling Method Non-Probability Sample
Study Population Patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection at a CALGB Lung Cancer Tissue Bank-approved institution.
Condition
  • Lung Carcinoma
  • Lung Neoplasm
  • Malignant Lung Neoplasm
Intervention Other: cytology specimen collection procedure
correlative studies
Other Name: cytologic sampling
Study Groups/Cohorts 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.
Intervention: Other: cytology specimen collection procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 10, 2015)
500
Original Enrollment Not Provided
Study Completion Date Not Provided
Estimated Primary Completion Date January 2100   (Final data collection date for primary outcome measure)
Eligibility Criteria
  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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00899782
Other Study ID Numbers CALGB-140202
CALGB-140202
CDR0000271323 ( Registry Identifier: NCI Physician Data Query )
U10CA031946 ( U.S. NIH Grant/Contract )
U10CA180821 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: William Richards, MD Brigham and Women's Cancer Center
PRS Account Alliance for Clinical Trials in Oncology
Verification Date February 2020