Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481813
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-05-23
Brief Title:
Prospective Longitudinal Biocollection in Thoracic Oncology Including Newly Diagnosed Lung Cancer Patients
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
BREATHE Cohort Prospective Longitudinal Biocollection in Thoracic Oncology Including Newly Diagnosed Lung Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREATHE
Brief Summary:
In clinical trials patients are selected according to strict eligibility criteria inclusion and exclusion criteria These criteria aim to ensure homogeneity within the trial population but may omit patients with specific characteristics comorbidities or co-medications Indeed patients of advanced age with comorbidities or brain metastases who are frequently encountered in clinical practice are often excluded from clinical trials Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies complementing data from controlled clinical trials They make it possible to analyze a larger population and take into account multiple variables such as patient history co-medications and comorbidities but also to analyze efficacy and toxicity data in populations not represented in clinical trials The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data including a maximum of data linked to the patient his tumor and his treatments collected longitudinally until the patients death or the end of the study
In parallel with this cohort the project aims to set up a longitudinal plasmatheque from diagnosis to death or at the end of the study as well as a tumorotheque samples systematically stored as part of care by the CHU tumorotheque and for which patient consent allows their use in research depending on the material available for patients with available tumor samples This will enable the construction of ancillary projects to validate research hypotheses for example concerning the identification of mechanisms of resistance to therapies
The main objective is to identify factors associated including biomarkers with response or resistance to anti-cancer therapies
In parallel with this cohort the project aims to set up a longitudinal plasmatheque from diagnosis to death or at the end of the study as well as a tumorotheque samples systematically stored as part of care by the CHU tumorotheque and for which patient consent allows their use in research depending on the material available for patients with available tumor samples This will enable the construction of ancillary projects to validate research hypotheses for example concerning the identification of mechanisms of resistance to therapies
The main objective is to identify factors associated including biomarkers with response or resistance to anti-cancer therapies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00509-38 | OTHER | None | None |