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OpenTrials
Completed

NCT Number: NCT00899782

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

correlative studies

Other names: cytologic sampling

Primary outcomes

  1. Collection and storage of frozen tissue samples for molecular analysisor resection of lung cancer

    Time frame: 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

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The CALGB Lung Cancer Tissue Bank

Important dates

Study start
2004
Primary completion
2022
Study completion
2022
First posted
May 12, 2009
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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