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
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Condition or disease | Intervention/treatment |
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Lung Carcinoma Lung Neoplasm Malignant Lung Neoplasm | Other: cytology specimen collection procedure |
OBJECTIVES:
- 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.
- 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.
- 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 |
Estimated Enrollment : | 500 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | The CALGB Lung Cancer Tissue Bank |
Study Start Date : | July 2004 |
Estimated Primary Completion Date : | January 2100 |

Group/Cohort | Intervention/treatment |
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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.
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Other: cytology specimen collection procedure
correlative studies
Other Name: cytologic sampling |
- 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 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- 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.
- No patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899782

Study Chair: | William Richards, MD | Brigham and Women's Cancer Center |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | 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 ) |
First Posted: | May 12, 2009 Key Record Dates |
Last Update Posted: | February 20, 2020 |
Last Verified: | February 2020 |
Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases |