Merkel Cell CarcinomaMERCCALIBINCT06448611
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
An observational study of Merkel Cell Carcinoma, run by University Hospital, Montpellier.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Merkel Cell Carcinoma
- What is being tested?
- Blood Test
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients managed for stage I to III Merkel cell carcinoma, for whom complete remission by complete surgical resection is planned (group B) or has been achieved recently, within 6 weeks prior to the inclusion visit (group A).
Who may be able to join
- Patients at least 18 years old
- Patients managed for stage I to III Merkel cell carcinoma,
- For whom complete remission by complete surgical resection is planned (group B) or has been achieved recently, within 6 weeks prior to the inclusion visit (group A).
Who cannot join
- Pregnant or breast-feeding women
- Failure to obtain written informed consent after a reflection period
- Participant in another research study with an ongoing exclusion period
- Not affiliated to a social security scheme
- Persons under court protection
- Patients unable to give consent, protected adults, vulnerable persons
- Stage IV disease or stage I to III disease for which complete remission is not envisaged
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Merkel Cell Carcinoma
- Being tested
- Blood Test
- Keywords
- Circulating Tumor Cells
- Medical subject headings
- Carcinoma, Merkel Cell, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TestOther
Research and quantification of Circulating Tumor Cells
| Study group | Role | What they receive |
|---|---|---|
| Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma | Entire cohort Receives: Other: Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumoral cells detection rate
Rate of patients with the presence of at least one CTC detected in the peripheral blood directly after the therapeutic sequence of surgery and radiotherapy, in absolute value
Measured: 6 weeks or less after the therapeutic sequence of surgery and radiotherapy
Secondary outcomes (1)
Change in the number of pre- and post-therapeutic circulating tumoral cells
Difference between the number of post-therapeutic CTCs (after surgery and radiotherapy) and the number of pre-therapeutic CTCs (for patients for whom a pre-therapeutic sample was available: group B patients), in absolute value
Measured: 6 weeks or less after the therapeutic sequence of surgery and radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Merkel Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448611
- Sponsor's protocol ID
- RECHMPL23_0452
- Acronym
- MERCCALIBI
- Status last verified
- May 2024
- First submitted
- 3 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06448611
- Acronym / sponsor ID
- MERCCALIBI / RECHMPL23_0452
- Conditions
- Merkel Cell Carcinoma
- Keywords
- Circulating Tumor Cells
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma | – | Other: Blood TestEntire cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients managed for stage I to III Merkel cell carcinoma, for whom complete remission by complete surgical resection is planned (group B) or has been achieved recently, within 6 weeks prior to the inclusion visit (group A).
Key inclusion criteria (3 listed)
- Patients at least 18 years old
- Patients managed for stage I to III Merkel cell carcinoma,
- For whom complete remission by complete surgical resection is planned (group B) or has been achieved recently, within 6 weeks prior to the inclusion visit (group A).
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding women
- Failure to obtain written informed consent after a reflection period
- Participant in another research study with an ongoing exclusion period
- Not affiliated to a social security scheme
- Persons under court protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood TestResearch and quantification of Circulating Tumor Cells | Other | Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma |
Primary outcome
Circulating tumoral cells detection rate
Time frame: 6 weeks or less after the therapeutic sequence of surgery and radiotherapy
Rate of patients with the presence of at least one CTC detected in the peripheral blood directly after the therapeutic sequence of surgery and radiotherapy, in absolute value
1 secondary outcome
Change in the number of pre- and post-therapeutic circulating tumoral cells
Time frame: 6 weeks or less after the therapeutic sequence of surgery and radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Merkel Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
Dermatologic Conditions, Healthy Volunteers
Not yet recruitingPhase 1/2
ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1
Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage III
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Merkel Cell Carcinoma, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Dereure, Pr (0467336906, o-dereure@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumoral cells detection rate (time frame: 6 weeks or less after the therapeutic sequence of surgery and radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.