Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2011 |
| Contact: | Hong Ma, MD |
| Email: | rd110@ptilabs.com |
| Phone: | 1-877-233-7090 |
Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer
A 15-gene lung signature was created to identify predictive and prognostic biomarkers for
Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a
microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk
and low risk cohorts with significantly different survivals.
Using fresh frozen tissue can be challenging, so this study attempts simplify the process by
migrating the 15-gene signature from fresh frozen to two alternative tissue formats:
Formalin Fixed Paraffin Embedded (FFPE) and RNAlater.
The gene expressions of the different tissue formats will be compared to see if the fresh
frozen tissue results are similar to the alternative tissue formats.
Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a
microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk
and low risk cohorts with significantly different survivals.
Using fresh frozen tissue can be challenging, so this study attempts simplify the process by
migrating the 15-gene signature from fresh frozen to two alternative tissue formats:
Formalin Fixed Paraffin Embedded (FFPE) and RNAlater.
The gene expressions of the different tissue formats will be compared to see if the fresh
frozen tissue results are similar to the alternative tissue formats.
Patients with early stage NSCLC will be consented prior to surgery so that any excess tissue
collected during surgery can be collected in one of the three tissue formats (Fresh Frozen,
FFPE, RNAlater) and sent to the Sponsor for testing.
collected during surgery can be collected in one of the three tissue formats (Fresh Frozen,
FFPE, RNAlater) and sent to the Sponsor for testing.
Inclusion Criteria:
- New diagnosis of stage I or II Non-Small Cell Lung Cancer (NSCLC)
- Must have resectable disease and complete surgical resection planned
- Histologically or cytologically confirmed adenocarcinoma, squamous or large cell
carcinoma NSCLC
- No prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for
this cancer
- Tumor specimen samples must be collected within 1 hour of surgery
- Patient must be at least 18 years of age
- Patient must sign and date an approved study consent form
Exclusion Criteria:
- Patients with psychiatric or addictive disorders that would preclude obtaining study
consent
- Informed consent obtained the same day as surgery
- Absence of histological diagnosis of lung cancer
- Known infectious disease
- History of chemotherapy, biologic/molecular targeted therapy or radiation therapy for
this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e.
rheumatoid arthritis
We found this trial at
7
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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