Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Advanced stage (IIIB to IV) non-small cell lung cancer (all types including mixed histology, without actionable mutations)
Disqualifiers
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.
Trial population
Participants will be recruited from the patient population of The University of Kansas and affiliated sites.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood and Tissue Collection
Other interventionSamples 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.
Treatment groups
110 Participants
are divided into 4 treatment groupsGroup A: Stage IIIB, IIIC or IV Non-small cell lung cancer1 intervention
Group B: Extensive-stage Small-cell lung cancer1 intervention
Group C: Metastatic squamous cell Head and Neck cancer1 intervention
Group D: Malignant Pleural Mesothelioma1 intervention
Trial outcomes
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.
Time frame
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 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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