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 (MERCCALIBI)

June 11, 2024 updated by: University Hospital, Montpellier

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma
Entire cohort
Other: Blood Test
Research and quantification of Circulating Tumor Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks or less after the therapeutic sequence of surgery and radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
6 weeks or less after the therapeutic sequence of surgery and radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL23_0452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Merkel Cell Carcinoma

Clinical Trials on Blood Test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe