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

NCT ID: NCT00899782

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-15

Study Completion Date

2022-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Carcinoma Lung Neoplasm Malignant Lung Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

cytology specimen collection procedure

Intervention Type OTHER

correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cytology specimen collection procedure

correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cytologic sampling

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

2. No patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William Richards, MD

Role: STUDY_CHAIR

Brigham and Women's Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Union Hospital of Cecil County

Elkton, Maryland, United States

Site Status

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, United States

Site Status

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, United States

Site Status

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Site Status

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Site Status

Veterans Affairs Medical Center - Asheville

Asheville, North Carolina, United States

Site Status

Duke Cancer Institute

Durham, North Carolina, United States

Site Status

Forbes Regional Hospital

Monroeville, Pennsylvania, United States

Site Status

Alle-Kiski Medical Center

Natrona Heights, Pennsylvania, United States

Site Status

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CALGB-140202

Identifier Type: -

Identifier Source: secondary_id

CDR0000271323

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CALGB-140202

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.