Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology

NCT07550049 | Not Yet Recruiting

• 1 other identifier: STUDY00162327
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head and Neck Cancer; Malignant Pleural Mesothelioma; Small Cell Lung Cancer

Keywords

Biobank; Blood bank; Tissue bank

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Stage IIIB, IIIC or IV Non-small cell lung cancer

Participants with non-small cell lung cancer.

Other: Blood and Tissue Collection

Extensive-stage Small-cell lung cancer

Participants with extensive stage small-cell lung cancer.

Other: Blood and Tissue Collection

Metastatic squamous cell Head and Neck cancer

Participants with metastatic squamous-cell head and neck cancer.

Other: Blood and Tissue Collection

Malignant Pleural Mesothelioma

Participants with advanced malignant pleural mesothelioma.

Other: Blood and Tissue Collection

Interventions

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.

Extensive-stage Small-cell lung cancer; Malignant Pleural Mesothelioma; Metastatic squamous cell Head and Neck cancer; Stage IIIB, IIIC or IV Non-small cell lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the patient population of The University of Kansas and affiliated sites.

You may qualify if:

• 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:
• Advanced stage (IIIB to IV) non-small cell lung cancer (all types including mixed histology, without actionable mutations)
• Extensive-stage small cell lung cancer that are treatment naïve that will receive immunotherapy and chemotherapy
• Recurrent or metastaƟc squamous cell head and neck cancers, squamous cell, HPV posiƟve or HPV negaƟve, treatment naïve that will start immunotherapy and chemotherapy
• Malignant pleural mesothelioma that will be treated with immunotherapy and chemotherapy
• Eligible to receive chemotherapy (plaƟnum 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.

You may not qualify if:

• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation.
• Advanced stage (IIIB to IV) non-small cell lung cancer with actionable mutations
• Active viral infection (Hep C or B) requiring anti-viral therapy in the last 28 days. HIV patients on stable on anti-viral therapy able to receive therapy for the cancer are eligible to participate.
• Active use of prednisone equivalent to more than 10mg/day
• Second malignancy that requires systemic treatment at the time of consent

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Head and Neck Neoplasms; Mesothelioma, Malignant

Interventions

Blood Specimen Collection; Tissue Banks

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Chao Huang, MD

  The University of Kansas Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margana Whyte

CONTACT

(913) 945-6050; mwhyte@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share