Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04258137
Status:
RECRUITING
Last Update Posted:
2023-03-02
First Post:
2020-02-04
Brief Title:
Circulating DNA to Improve Outcome of Oncology PatiEnt A Randomized Study
Sponsor:
Institut Bergonié
Organization:
Institut Bergonié
Study Overview
Official Title:
Circulating DNA to Improve Outcome of Oncology PatiEnt A Randomized Study - COPE Study
Status:
RECRUITING
Status Verified Date:
2023-03
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:
COPE
Brief Summary:
COPE is a biology driven protocol with 2 independent multicentric two-arm non-comparative randomized 21 phase II trials in 2 distinct populations colorectal cancer patients and non-small-lung cancer patients
For each phase II trial patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B
Arm A Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis
Arm B Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging
For each phase II trial patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B
Arm A Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis
Arm B Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging
Detailed Description:
Primary tumor tissue if accessible at all does not always provide enough information to stratify individual patients to the most promising therapy Re-analysis of metastatic lesions by needle biopsy is possible but invasive and limited by the known intra-patient heterogeneity of individual lesions These hurdles might be overcome by analyzing circulating tumor DNA liquid biopsy which in principle might reflect all subclones present at that specific time point and allow sequential monitoring of disease evolution
Once tumors genetic profiling is available patients will be discussed within a multidisciplinary tumor board MTB which aims at discussing the genomic profiles and at providing a therapeutic decision for each patient This MTB involves clinical oncologists molecular biologists and clinical or biological project manager
All the patients carrying an actionnable alteration will be proposed to receive a matched drug or to enter in a matched clinical trial depending on the possibility of inclusion at the time of molecular report
the investigators hypothesize that implementing sequential circulating tumor DNA analysis can improve management of patients with advanced cancer and therefore their survival
Once tumors genetic profiling is available patients will be discussed within a multidisciplinary tumor board MTB which aims at discussing the genomic profiles and at providing a therapeutic decision for each patient This MTB involves clinical oncologists molecular biologists and clinical or biological project manager
All the patients carrying an actionnable alteration will be proposed to receive a matched drug or to enter in a matched clinical trial depending on the possibility of inclusion at the time of molecular report
the investigators hypothesize that implementing sequential circulating tumor DNA analysis can improve management of patients with advanced cancer and therefore their survival
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 |
|---|---|---|---|
| 2019-A02479-48 | OTHER | None | None |
| ML41112 | OTHER | Roche ID | None |