Stage IIIb and IV Non Small Cell Lung Cancer Clinical Trial
— ANTiCIPeOfficial title:
Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA
| Verified date | October 2015 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ethic Comitee |
| Study type | Observational |
The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | September 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Signed written informed consent - Male or female aged >= 18 years - Stage IIIb and IV Non Small Cell Lung Cancer histologically confirmed Exclusion Criteria: - Tissue and plasma samples can not be provided for mutation analysis - Unwilling or unable to provide informed consent - Any serious medical condition that would interfere with the subject's safety |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | CHU | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital | Roche Pharma AG |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mutation profiling of circulating tumor DNA from plasma samples. | To evaluate the sensitivity of NGS to detect the genetic alterations in plasma tumor DNA. | 1 year | No |
| Secondary | Quantity of circulating tumor DNA in serially collected plasma specimens. | To evaluate the change of quantity of circulating tumor DNA during treatment. | 1 year | No |