Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448611
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-03
Brief Title:
Identification and Characterization of Circulating Tumor Cells Before and After Treatment Surgery and Radiotherapy in a Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Identification and Characterization of Circulating Tumor Cells Before and After Treatment in a Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
MERCCALIBI
Brief Summary:
The goal of this prospective observational study is to evaluate the presence of circulating tumoral cells in patients over 18 with a stage I-III resectable Merkel cell carcinoma after the initial therapeutic sequence of surgery and radiotherapy The main question it aims to answer is
Can any residual disease be found in the form of circulating tumoral cells in blood samples of patients treated with surgery and radiotherapy for a resectable stage I to III Merkel cell carcinoma When possible the circulating tumoral cells count will be compared to the one realized in a blood sample of the same patient before surgery and radiotherapy
Participants will
Have a blood sample taken before surgery if the patient is addressed to our center early enough
Have a blood sample taken immediately after surgery and radiotherapy for all
Two additional blood samples will be taken during the 6-months and 12-months visit to set up a biobank
Can any residual disease be found in the form of circulating tumoral cells in blood samples of patients treated with surgery and radiotherapy for a resectable stage I to III Merkel cell carcinoma When possible the circulating tumoral cells count will be compared to the one realized in a blood sample of the same patient before surgery and radiotherapy
Participants will
Have a blood sample taken before surgery if the patient is addressed to our center early enough
Have a blood sample taken immediately after surgery and radiotherapy for all
Two additional blood samples will be taken during the 6-months and 12-months visit to set up a biobank
Detailed Description:
The main goal of this study is to evaluate the presence of circulating tumoral cells in patients circulating tumoral cells after surgery and radiotherapy in patients with stage I to III Merkel cell carcinoma
Another goal will be to track changes in the number of circulating tumoral cells before and after treatment in patients with stage I to III Merkel cell carcinoma who have had a blood sample taken before starting treatment
Investigators will also set up a biobank which is a collection of blood samples taken every six months for one year These samples will help with future research
The study will include patients over 18 years old with stage I to III Merkel cell carcinoma treated at the Dermatology Departments of Montpellier and Nimes University Hospitals Investigators will not include pregnant or breastfeeding women patients not covered by social security those under court protection those unable to give consent or those with stage IV Merkel cell carcinoma or stage I to III Merkel cell carcinoma where complete remission is not possible All patients will give free and informed consent to participate
Patients will be divided into two groups based on when they are referred to the university hospital for treatment
Group A If the tumor is fully removed before the patient is referred to the hospital
Group B If the tumor is still present when referred to the hospital This can happen if
Only a biopsy has been done to confirm the tumor
The tumor was removed but it is stage III with lymph node involvement Both scenarios will not affect the main goal checking for circulating tumoral cells after treatment However the change in circulating tumoral cell numbers before and after treatment can only be checked in Group B where patients had a blood sample taken before treatment
Both groups will have follow-up visits at 6 and 12 months The main endpoint will be the circulating tumoral cell detection rate which is the presence of circulating tumoral cells in their blood right after surgery and radiotherapy Another measure will be the change in the number of circulating tumoral cells before and after treatment for those who had a blood sample taken before starting treatment
Another goal will be to track changes in the number of circulating tumoral cells before and after treatment in patients with stage I to III Merkel cell carcinoma who have had a blood sample taken before starting treatment
Investigators will also set up a biobank which is a collection of blood samples taken every six months for one year These samples will help with future research
The study will include patients over 18 years old with stage I to III Merkel cell carcinoma treated at the Dermatology Departments of Montpellier and Nimes University Hospitals Investigators will not include pregnant or breastfeeding women patients not covered by social security those under court protection those unable to give consent or those with stage IV Merkel cell carcinoma or stage I to III Merkel cell carcinoma where complete remission is not possible All patients will give free and informed consent to participate
Patients will be divided into two groups based on when they are referred to the university hospital for treatment
Group A If the tumor is fully removed before the patient is referred to the hospital
Group B If the tumor is still present when referred to the hospital This can happen if
Only a biopsy has been done to confirm the tumor
The tumor was removed but it is stage III with lymph node involvement Both scenarios will not affect the main goal checking for circulating tumoral cells after treatment However the change in circulating tumoral cell numbers before and after treatment can only be checked in Group B where patients had a blood sample taken before treatment
Both groups will have follow-up visits at 6 and 12 months The main endpoint will be the circulating tumoral cell detection rate which is the presence of circulating tumoral cells in their blood right after surgery and radiotherapy Another measure will be the change in the number of circulating tumoral cells before and after treatment for those who had a blood sample taken before starting 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