Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma

Adenocarcinoma

Adenocarcinoma in Situ

Adenocarcinoma, Bronchiolo-Alveolar

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Multifocal Tissue Banking

Marie Christine Aubry, MD

The investigators are doing this research to see if they can use small tissue samples or fluid to develop a test that will determine if the tissue samples are related or not related to each other. The test will use the patient's DNA, which is part of their unique genetic material that carries the instructions for the body's development and function. Cancer can result from changes in a person's genetic material that causes cells to divide in an uncontrolled way and, sometimes, to travel to other organs. Currently, researchers and doctors know some of the genetic changes that can cause cancer, but they do not know all of the genetic changes that can cause cancer.

A frequent clinical dilemma in lung cancer care is the management of multifocal lung cancers. The management decision is based on determining if multiple cancers represent true independent primary cancers or related metastasis. This determination is critical to the appropriate staging of the cancers and treatment. Indeed, this distinction represents the difference between aggressive local therapy with either surgery or radiation therapy for primary early stage lesions, or palliative chemotherapy or best supportive care with appropriate symptom management for advanced stage metastatic disease.

No existing pathologic or molecular test is currently capable of making the distinction between multiple independent lung primaries from metastatic disease with accuracy. The recent release of preliminary data from the NLST screening trial, suggesting survival benefit for screening high risk patients with CT scanning, will only increase the number of patients facing these treatment dilemmas. The research team has recently developed a test that allows this distinction with great accuracy. This test allows determination of lineage between two tumors using the identification of large genomic rearrangements using mate pair next generation sequencing (MP). The test has been developed using fresh frozen tissue from resected lung tumors and is currently being validated for a clinical test.

The investigators' goal is to develop the test using cytology and small biopsy specimens.

The patient will have some or all of the samples taken listed below:

* Blood sample of 10 ml (2 teaspoons).
* Up to two lung bronchoscopic or transbronchoscopic needle aspiration biopsies will be given to the research study during an already scheduled bronchoscopy. In addition at the time of the bronchoscopy a brushing or washing specimen could be collected for research.
* A piece of lung or lymph node tissue taken at the time of the CT guided lung or lymph node biopsy will be given to the research study.
* A piece of lung tumor tissue removed during surgery will be given to the research study.
* If pleural fluid is removed as part of the procedure(s) and there is any fluid left after what is needed for your clinical care, it will be given to the research study.
* DNA genome sequencing will be performed on the collected tissues, blood and fluid.

A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing

A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome

Performance of the mate pair next generation sequencing lineage test on cytology and small biopsy specimens obtained as part of routine clinical practice, through either a bronchoscopic, CT-guided needle procedure, or lung resection as evidenced in receiving results from the sequencing.

Mayo Clinic

MD, Principal Investigator

Rare Diseases

Adenocarcinoma of Lung

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.

Multifocal Lung Adenocarcinoma

Dennis Wigle, MD, PhD

To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.

Lung bronchoalveolar carcinoma (BAC) or adenocarcinoma in situ (AIS) continues to represent a poorly understood clinical entity. A frequent clinical dilemma in lung cancer care is the management of a documented or suspected invasive adenocarcinoma in the setting of multifocal ground glass opacity (GGO) consistent with multifocal AIS. These patients are typically classified as stage IV disease, and treated with palliative chemotherapy. No existing pathologic or molecular test is currently capable of making the distinction between independent primary versus metastatic tumors, a distinction for which substantial treatment impact exists. Many treating physicians suspect that outcomes for this specific patient subgroup are better than norms for stage IV disease, as such patients are frequently node-negative and without distant metastases despite multiple lesions present. To address this issue, we will evaluate a multimodality treatment protocol using aggressive local and targeted systemic therapy for multifocal lung adenocarcinoma, incorporating information from tumor genome sequencing for individualized treatment planning. The results will have significant impact in advancing the biologic understanding and treatment approach for lung adenocarcinoma in the setting of multifocal AIS.

Treatment of Multifocal Lung Adenocarcinoma

A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing

Overall survival compared to survival for Stage IV NSCLC on NCCTG trials

Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry)

MD, PhD

Patients with ground glass opacity featured lung adenocarcinoma who are candidates for surgery.

Haiquan Chen, M.D.

This study is one of the Eastern Cooperative Thoracic Oncology Projects (ECTOP-1011). It aims to evaluate the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma via whole-mount section.

The pathological lepidic growth pattern was believed to relate to the ground-glass component, whereas invasive adenocarcinoma patterns relate to the solid component. However, the solid components might be fibrosis rather tumor; and previous studies demonstrated the ground-glass components might be invasive lesions. Therefore, it is of considerable significance to establish the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma.

Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS (ECTOP-1011)

Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of Ground Glass Opacity Featured Lung Adenocarcinoma Via Whole-Mount Section

Evaluation of correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma

The specificity, sensitivity, and repeatability of invasiveness diagnosis based on the Whole-Mount Section

Fudan University

Professor

Symptoms and General Pathology

Disease Progression

No intercention

Qun Wang

In this study, about 2000 GGO patients will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion and provide evidence for GGO treatment.

Progression of Untreated Pulmonary Ground Glass Opacity

Shanghai Zhongshan Hospital

Multiple Pulmonary Nodules

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

LungBrella marker implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery

The enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software. The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection .

LungBrella marker implantation and VATS partial lobe resection

Hecheng Li, MD&PHD

As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients

This is a prospective, single-center clinical trial initiated by the investigator. LungBrella marker can be accurately implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery. The study is expected to enroll 10 patients. Finally, the effectiveness and safety of the method will be evaluated. This method not only can complete pulmonary nodule localization in the operating room without occupying the resources of radiology department, but also can let patients receive pulmonary nodule location after anesthesia. Thereby the risks during transportation are avoided and the suffering of patients is reduced.

Safety and Feasibility of Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules

Safety and Feasibility of a Novel Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules

When the distance between the LungBrella marker and the Pulmonary nodule is less than 10mm, the marker position is successful. The success rate is the proportion of successful cases to all operation cases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing	NCT02705404	Lung Neoplasms Carcinoma Non-s...	Multifocal Tiss...	18 Years -	Mayo Clinic
Treatment of Multifocal Lung Adenocarcinoma	NCT01946100	Lung Neoplasms Carcinoma Non-s... Adenocarcinoma	Multifocal Lung...	18 Years -	Mayo Clinic
Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS (ECTOP-1011)	NCT05252676	Adenocarcinoma ...		18 Years -	Fudan University
A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing	NCT02705404	Lung Neoplasms Carcinoma Non-s...	Multifocal Tiss...	18 Years -	Mayo Clinic
Progression of Untreated Pulmonary Ground Glass Opacity	NCT03723629	Lung Cancer	No intercention	35 Years - 80 Years	Shanghai Zhongshan Hospital
Safety and Feasibility of Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules	NCT04211051	Lung Neoplasms	LungBrella mark...	18 Years - 70 Years	Ruijin Hospital
Progression of Untreated Pulmonary Ground Glass Opacity	NCT03723629	Lung Cancer	No intercention	35 Years - 80 Years	Shanghai Zhongshan Hospital
A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing	NCT02705404	Lung Neoplasms Carcinoma Non-s...	Multifocal Tiss...	18 Years -	Mayo Clinic
Safety and Feasibility of Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules	NCT04211051	Lung Neoplasms	LungBrella mark...	18 Years - 70 Years	Ruijin Hospital

Spots Global Cancer Trial Database for ground glass opacity