Prospective Evaluation of Single Cell Mutations in a Panel of Known Oncogenes in NSCLC Surgical Specimens (TAP-NSCLC)
Prospective Evaluation of Single Cell Mutations in a Panel of Known Oncogenes in NSCLC Surgical Specimens (TAP-NSCLC)
Study Overview
Detailed Description
NSCLC is a particularly heterogeneous disease with different genetic alterations in oncogenes 'drivers', responsible for the development and progression of the disease. In most cases all these anomalies represent clonal mutations in all neoplastic cells. However, several sub-clonal genetic alterations were identified in some multi-regional sequencing studies, demonstrating an intra-tumor heterogeneity. Tracing the clonal architecture of the disease and also the temporal order of the various mutations appearance, would bring two benefits:
- prioritize the molecular targets
- identify evolutionary trajectories associated with the outcome of therapies and survival, useful to stratify patients considering the likelihood and the duration of response For the bioinformatic data analyses will be used the Tapestri MissionBio pipeline.
Given the limited number of patients that can be included in the study (10 patients), no statistical analyzes will be performed. Results will be presented thorugh narrative reports for each patients.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
MB
-
Monza, MB, Italy, 20900
- Recruiting
- Fondazione IRCCS San Gerardo dei Tintori
-
Contact:
- Diego Cortinovis, MD
- Phone Number: +390392336040
- Email: diegoluigi.cortinovis@irccs-sangerardo.it
-
Contact:
- Elisa Sala, PhD
- Phone Number: +390392333203
- Email: onco.noprofit@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age over 18 years old.
- histological diagnosis of NSCLC technically operable following multidisciplinary discussion
- informed consent freely granted and obtained before the start of the study
Exclusion Criteria:
- age under 18 years old
- unconfirmed NSCLC histological diagnosis
- medical treatment with neoadjuvant purposes
- absence of informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tapestri success rate
Time Frame: 6 months
|
Evaluation of the feasibility of a single cell mutation search method in a panel of known oncogenes, using Tapestri technology, in tumor tissue obtained from stage I-II-III NSCLC patients after surgical treatment planned in clinical practice.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAP-NSCLC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.