Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287814
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-08
Brief Title:
French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients FRENCHMRDCRC
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
French Assessment of Minimal Residual Disease by Liquid Biopsies in Stage III Colorectal Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies Currently for colorectal cancer the methods used to decide who gets additional post-surgery treatment are suboptimal Some patients get too much treatment while others do not get enough
There is a new way to explore if there is any cancer left in a patients body using circulating tumor DNA ctDNA detected in blood samples This can help decide who needs more treatment after surgery Even though many tests have been developed it has yet to be determined which test performs best at relevant time points
The GUIDEMRD consortium is a group of experts including scientists technology and pharmaceutical companies The consortium is working on creating a reliable standard for the ctDNA tests validating their clinical utility and collecting data to help decide on the best treatment for each patient
FRENCH-MRD-CRC is the French study of the european GUIDEMRD project
There is a new way to explore if there is any cancer left in a patients body using circulating tumor DNA ctDNA detected in blood samples This can help decide who needs more treatment after surgery Even though many tests have been developed it has yet to be determined which test performs best at relevant time points
The GUIDEMRD consortium is a group of experts including scientists technology and pharmaceutical companies The consortium is working on creating a reliable standard for the ctDNA tests validating their clinical utility and collecting data to help decide on the best treatment for each patient
FRENCH-MRD-CRC is the French study of the european GUIDEMRD project
Detailed Description:
FRENCHMRDCRC is a part of WP3 of the overarching GUIDEMRD project Each study chair has a local clinical trial protocol where patients are recruited After the end of recruitment samples will be analyzed under the GUIDEMRD consortium
The overall aim of GUIDEMRD is to investigate the clinical utility of ctDNA analysis to predict and guide the choice of multi-modal therapies prospectively The fundamental steps towards this aim are assessment and benchmarking of the many available ctDNA diagnostics to identify the best-suited tests for clinical application Clinical samples will be used to benchmark ctDNA diagnostics and assess their true clinical performance The samples should reflect clinical situations where the ctDNA diagnostics are particularly useful such as post-operatively post-adjuvant during chemotherapy and longitudinally during post-treatment surveillance In these situations ctDNA diagnostics could be used to either monitor treatment response in case of MRD after surgery or to identify relapse at an early time point Based on ctDNA information medical treatment could be changed or radiology could be used to reveal the location of residual disease
The rationale for the observational clinical study FRENCHMRDCRC is to prospectively collect the clinical samples needed to enable assessment of the performance of ctDNA diagnostics in the setting of colorectal cancer CRC There are two main scenarios where ctDNA diagnostic is useful in CRC
Stage III CRC locally advanced non-metastasized disease This patient group is particularly relevant because adjuvant therapy is recommended for all stage III patients due to their high recurrence risk 25 Nevertheless most patients do not recur and most of these do not need therapy at all because they were already cured by surgery alone which leads to substantial overtreatment Furthermore the 25 of patients who recur despite both surgery and adjuvant therapy probably could benefit from further multimodal therapies The challenge is however that currently there is no marker in clinical use that can identify those patients with residual disease and need for therapy Circulating tumor DNA is potentially such a marker However currently it is unknown which if any of the many different ctDNA diagnostics developed in recent years have the required performance to provide clinical utility in the management of stage III CRC This clinical dilemma will be addressed with the first cohort of GUIDEMRD-01-CRC
The FRENCHMRDCRC study is logistically divided into two parts and patients are offered participation in each part separately The parts are called FRENCHMRDCRC part 1 - SURGERY and FRENCHMRDCRC part 2 - SURVEILLANCE
In FRENCHMRDCRC part 1 blood samples are collected before and after intended curative surgery In FRENCHMRDCRC part 2 blood samples are collected immediately after adjuvant chemotherapy and during standard-of-care surveillance Using the patients included in FRENCHMRDCRC part 1 the Primary objective 1 P1 will be addressed
The subset of the part I patients that are also included in FRENCHMRDCRC part 2 will be used to address the Primary objective P2 and Secondary objectives S1-S5 see below
All FRENCHMRDCRC patients parts 1 and 2 are followed 3 years from the date of surgery
PRIMARY OBJECTIVES Primary objective 1 P1 To confirm that ctDNA analysis performed immediately after CRC treatment can identify patients with a high risk of recurrence
Specifically the investigators want to determine the association between 3-year disease-free survival DFS and ctDNA detection status immediately after
1 Curative intended surgery and
2 Adjuvant chemotherapy
Primary objective 2 P2 To identify a cohort of UICC stage III CRC patients with planned adjuvant chemotherapy These patients will be offered enrollment in the FRENCHMRDCRC part II and will further be included in a European collaboration named GUIDEMRD funded by the European Union via the Innovative Health Initiative
SECONDARY OBJECTIVES Secondary objective 1 S1 To technically assess compare and rank existing commercial ctDNA diagnostics after intended curative CRC treatment surgery and adjuvant chemotherapy to identify the best method at each time point with no impact on diagnosis or treatment of patients enrolled in the study
Secondary objective 2 S2
To assess the effect of standard-of-care adjuvant chemotherapy on the level of ctDNA Especially for patients with ctDNA detected after surgery the investigators will measure and compare the ctDNA levels in plasma samples drawn before and after adjuvant chemotherapy Further the change in ctDNA level will be correlated to the oncological outcomes time to clinical recurrence disease-free survival and overall survival
Secondary objective 3 S3 To investigate if time to Molecular recurrence determined using serial ctDNA analyses in longitudinally collected plasma samples is shorter than time to Clinical recurrence using standard-of-care radiological imaging
Secondary objective 4 S4 To investigate the correlation between ctDNA analysis results and findings on CT scans ctDNA analysis will be restricted to blood sampling times that are coinciding with standard-of-care CT scans during standard-of care surveillance If ctDNA analysis can predict the outcome of the CT scan the potential is that ctDNA analysis in the future can guide when to perform CT scans
Secondary objective 5 S5 To investigate the prognostic power of ctDNA at the time point of indeterminate CT scans
Secondary objective 6 S6 To create a unique biobank of plasma and tissue samples from stage I to III CRC patients collected before any treatment
The overall aim of GUIDEMRD is to investigate the clinical utility of ctDNA analysis to predict and guide the choice of multi-modal therapies prospectively The fundamental steps towards this aim are assessment and benchmarking of the many available ctDNA diagnostics to identify the best-suited tests for clinical application Clinical samples will be used to benchmark ctDNA diagnostics and assess their true clinical performance The samples should reflect clinical situations where the ctDNA diagnostics are particularly useful such as post-operatively post-adjuvant during chemotherapy and longitudinally during post-treatment surveillance In these situations ctDNA diagnostics could be used to either monitor treatment response in case of MRD after surgery or to identify relapse at an early time point Based on ctDNA information medical treatment could be changed or radiology could be used to reveal the location of residual disease
The rationale for the observational clinical study FRENCHMRDCRC is to prospectively collect the clinical samples needed to enable assessment of the performance of ctDNA diagnostics in the setting of colorectal cancer CRC There are two main scenarios where ctDNA diagnostic is useful in CRC
Stage III CRC locally advanced non-metastasized disease This patient group is particularly relevant because adjuvant therapy is recommended for all stage III patients due to their high recurrence risk 25 Nevertheless most patients do not recur and most of these do not need therapy at all because they were already cured by surgery alone which leads to substantial overtreatment Furthermore the 25 of patients who recur despite both surgery and adjuvant therapy probably could benefit from further multimodal therapies The challenge is however that currently there is no marker in clinical use that can identify those patients with residual disease and need for therapy Circulating tumor DNA is potentially such a marker However currently it is unknown which if any of the many different ctDNA diagnostics developed in recent years have the required performance to provide clinical utility in the management of stage III CRC This clinical dilemma will be addressed with the first cohort of GUIDEMRD-01-CRC
The FRENCHMRDCRC study is logistically divided into two parts and patients are offered participation in each part separately The parts are called FRENCHMRDCRC part 1 - SURGERY and FRENCHMRDCRC part 2 - SURVEILLANCE
In FRENCHMRDCRC part 1 blood samples are collected before and after intended curative surgery In FRENCHMRDCRC part 2 blood samples are collected immediately after adjuvant chemotherapy and during standard-of-care surveillance Using the patients included in FRENCHMRDCRC part 1 the Primary objective 1 P1 will be addressed
The subset of the part I patients that are also included in FRENCHMRDCRC part 2 will be used to address the Primary objective P2 and Secondary objectives S1-S5 see below
All FRENCHMRDCRC patients parts 1 and 2 are followed 3 years from the date of surgery
PRIMARY OBJECTIVES Primary objective 1 P1 To confirm that ctDNA analysis performed immediately after CRC treatment can identify patients with a high risk of recurrence
Specifically the investigators want to determine the association between 3-year disease-free survival DFS and ctDNA detection status immediately after
1 Curative intended surgery and
2 Adjuvant chemotherapy
Primary objective 2 P2 To identify a cohort of UICC stage III CRC patients with planned adjuvant chemotherapy These patients will be offered enrollment in the FRENCHMRDCRC part II and will further be included in a European collaboration named GUIDEMRD funded by the European Union via the Innovative Health Initiative
SECONDARY OBJECTIVES Secondary objective 1 S1 To technically assess compare and rank existing commercial ctDNA diagnostics after intended curative CRC treatment surgery and adjuvant chemotherapy to identify the best method at each time point with no impact on diagnosis or treatment of patients enrolled in the study
Secondary objective 2 S2
To assess the effect of standard-of-care adjuvant chemotherapy on the level of ctDNA Especially for patients with ctDNA detected after surgery the investigators will measure and compare the ctDNA levels in plasma samples drawn before and after adjuvant chemotherapy Further the change in ctDNA level will be correlated to the oncological outcomes time to clinical recurrence disease-free survival and overall survival
Secondary objective 3 S3 To investigate if time to Molecular recurrence determined using serial ctDNA analyses in longitudinally collected plasma samples is shorter than time to Clinical recurrence using standard-of-care radiological imaging
Secondary objective 4 S4 To investigate the correlation between ctDNA analysis results and findings on CT scans ctDNA analysis will be restricted to blood sampling times that are coinciding with standard-of-care CT scans during standard-of care surveillance If ctDNA analysis can predict the outcome of the CT scan the potential is that ctDNA analysis in the future can guide when to perform CT scans
Secondary objective 5 S5 To investigate the prognostic power of ctDNA at the time point of indeterminate CT scans
Secondary objective 6 S6 To create a unique biobank of plasma and tissue samples from stage I to III CRC patients collected before any treatment
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