Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an ancillary laboratory study to collect and bank blood and tissue samples. The biospecimens collected for this study will be invaluable for future research into predictive biomarkers and genomic alterations and their correlation with clinical outcomes.
The goal of this study is to advance the research into the mechanism of resistance and genomic evaulation during therapy, serial blood samples will be collected from patients with advanced-stage non-small cell lung cancer, extensive-stage small cell lung cancer, metastatic squamous cell carcinoma of the head and neck, and malignant pleural mesothelioma who are inititating immunotherapy, with or without chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage IIIB, IIIC or IV Non-small cell lung cancer | Participants with non-small cell lung cancer. |
| |
| Extensive-stage Small-cell lung cancer | Participants with extensive stage small-cell lung cancer. |
| |
| Metastatic squamous cell Head and Neck cancer | Participants with metastatic squamous-cell head and neck cancer. |
| |
| Malignant Pleural Mesothelioma | Participants with advanced malignant pleural mesothelioma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and Tissue Collection | Other | Samples will be collected at baseline (prior to treatment), over four cycles of therapy, at six months, and at disease progression. When available, formalin-fixed paraffin-embedded (FFPE) tissue samples will also be obtained. Tissue samples of the biopsy or additional biopsy done as part of standard of care during the course of treatment will also be collected if available. Specimen number of the biopsy or additional biopsy done as part of standard of care during the course of treatment will also be collected. Specimen number for tissue will be collected to reference for future tissue collection. |
| Measure | Description | Time Frame |
|---|---|---|
| Establish a comprehensive blood and tissue biobank | To establish a comprehensive blood and tissue biobank from patients with advanced-stage non-small cell and extensive-stage small cell lung, metastatic squamous cell head and neck cancer and malignant pleural mesothelioma who are initiating first-line chemo-immunotherapy, with the goal of supporting future genomic research. | Samples will be collected at baseline (prior to treatment), over four cycles of therapy, at six months, and at disease progression; total participant duration minimum of 1 year |
Not provided
Not provided
Inclusion Criteria:
Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote consenting allowed per IRB policy.
Stated willingness to comply with all study procedures and availability for the duration of the study
Males and/or females age ≥ 18 years
Diagnosis of one of the following:
Eligible to receive chemotherapy (plaÆŸnum based) with an immune checkpoint inhibitor (single or double agents).
Able to provide consent to obtain a blood sample, prior future genomic research of their samples.
Planning to start therapy in the next 28 days.
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants will be recruited from the patient population of The University of Kansas and affiliated sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margana Whyte | Contact | (913) 945-6050 | mwhyte@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chao Huang, MD | The University of Kansas Cancer Center | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D006258 | Head and Neck Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014015 | Tissue Banks |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood and tissue samples
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D018070 | Biological Specimen Banks |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |