Comparison of micro arrays from biopsy material and surgical specimen for the 72 gene- prognostic profile of non-small cell lung cancer.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Can the prognosis profile (or other genomic profiles) be performed on biopsy
material (feasibility) and is the gene expression in the biopsy sample
comparable to the expression in the surgical specimen?
Secondary outcome
- What percentage of mismatch is due to heterogeneity within the tumor?
- What percentage of biopsies has too little (less than 30%) or no cancer cells
as assessed by H&E staining?
- To what degree correlate the results from biopsy with the results from
surgical specimen based on microarray results as well as IHC markers?
Background summary
Current staging methods are imprecise for predicting the outcome of treatment
of non*small cell lung cancer (NSCLC). In previous research we used
whole-genome gene expression micro arrays to analyze frozen-tumor samples from
103 patients (pT1&2, N0&1, MO), who had undergone complete surgical resection
in 5 European institutions. The developed 72-gene prognostic profile can
identify early stage NSCLC patients with a low-risk for disease recurrence
within three years after initial diagnosis.
However, for the full validation of a prognostic test, additional validation
studies are required. Additionally, for the use in clinical routine, the
prognostic test has to be adapted to a robust and standardized test with
stringent quality controls. Previously the prognostic profile has been analyzed
from frozen resection specimens, which are not widely available. Besides that,
diagnostically it would be an addition to be able to use the prognostic profile
on smaller biopsies, before performing a resection.
Study objective
Comparison of micro arrays from biopsy material and surgical specimen for the
72 gene- prognostic profile of non-small cell lung cancer.
Study design
Prospective study to compare the prognosis profile results from biopsy material
taken before surgery with surgical material from the same patient with NSCLC.
25 patients will be included. Of 5 patients 6 samples will be obtained from the
surgical resection material, from the following 20 patients both pre- and
peroperative samples will be obtained.
Study burden and risks
Biopsies will be taken during routine examination and treatment, which
minimizes the burden for the patient to a small extent. No additional risks are
expected. There will be no direct benefit for indivudual patients. After
complete validation of PulmoPrint has taken place benefit can be axpected for a
larger group of NSCLC patients stage I or II.
postbus 90203
1006 BE Amsterdam
NL
postbus 90203
1006 BE Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Patients with stage I or II of NSCLC who will undergo a resection
2. All histological subtypes of NSCLC
3. signed Informed consent
Exclusion criteria
1. Prior radiotherapy to target tumor
2. neo adjuvant treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27970.031.09 |