View Cancer Clinical Trials
Feasibility and clinical impact of next generation genomic sequencing in selected solid tumor patients
|Head & Neck
|High Grade Glioma
- To evaluate the feasibility of conducting genomic analyses on tumor tissues collected from solid tumor patients seen at the Cleveland Clinic. Feasibility will be defined as the proportion of patients signing consent who are able to have tumor tissue shipped to Foundation Medicine within 14 days of patient consent.
We will evaluate what proportion of patients have a result delivered from Foundation Medicine within 21 days of shipment of sample to them.To analyze what proportion of genomic analyses yield actionable genetic aberrations, and what proportion lead to change in patient management plan. Actionable will be defined as a mutation linked to an approved therapy in the solid tumor under study or another solid tumor, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration.To evaluate clinical outcomes of specific therapies chosen to target these aberrations. Standard clinical outcome measures (objective response rate, progression-free survival) will be captured.To evaluate the cost implications associated with this testing and subsequent treatment selection, compared with non-genomic-directed standard of care therapy.
- To evaluate the time it takes for Foundation Medicine to provide results.
- Solid tumor with a confirmed histopathologic diagnosis falling into one of the following categories and without a known curative therapeutic option:
- Metastatic/locally-advanced carcinoma of unknown primary - this includes tumors in which the pathology reads poorly differentiated (adeno)carcinoma in which the primary organ site cannot be discerned with certainty despite adequate clinical, laboratory and radiologic investigations
- Metastatic/locally-advanced non-small cell lung cancer in a non/light/distant smoker (less than 10 pack-years smoking history, or quit smoking more than 15 years prior) without known EGFR or EML4-ALK mutation in the tumor
- Unresectable pancreatobiliary cancer
- Head and neck squamous cell carcinoma, after failure of primary therapy
- Metastatic/unresectable pleural mesothelioma
- Metastatic breast cancer: either triple-negative-defined as ER-negative (<1%), PR-negative (<1%), HER2 non-amplified (IHC 0/1 or FISH ratio <2.0) at any line of therapy; or hormone receptor positive/HER2 negative that are endocrine therapy and/or chemotherapy resistant (progressed on more than 2 lines of endocrine therapy and/or more than 2 chemotherapy regimens in the metastatic setting)
- Metastatic colorectal cancer
- Age ≥ 18 years
- ECOG performance status 0, 1 or 2
- Measurable and/or evaluable disease per RECIST version 1.1
- Prior therapies (e.g. chemotherapy, targeted therapy, surgery, radiation) are permitted but not required
Exclusion Criteria Not Available
Cancer Answers & Appointments
Speak with a cancer nurse specialist for appointment assistance and for answers to your questions about cancer locally at 216.444.7923 or toll-free 1.866.223.8100.
Monday through Friday from 8 a.m. – 4:30 p.m. (ET).
Resources for medical professionals
- Outpatient appointment referrals: 216.444.7923 or 866.223.8100
- Inpatient hospital transfers: 800.553.5056
- Referring Physician Concierge: 216.444.6196 or 216.312.4910.
Search available cancer clinical trials by disease, hospital, phase or number.
This information is provided by Cleveland Clinic and is not intended to replace
the medical advice of your doctor or health care provider.
Please consult your health care provider for advice about a specific medical condition.
© Copyright 2015 Cleveland Clinic. All rights reserved.