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

NCT06448611 | Not Yet Recruiting

• 1 other identifier: RECHMPL23_0452
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Merkel Cell Carcinoma

Keywords

Circulating Tumor Cells

Outcome Measures

Primary Outcomes (1)

• 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

  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

  6 weeks or less after the therapeutic sequence of surgery and radiotherapy

Study Arms (1)

Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma

Entire cohort

Other: Blood Test

Interventions

Blood Test OTHER

Research and quantification of Circulating Tumor Cells

Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients at least 18 years old
• Patients managed for stage I to III Merkel cell carcinoma,

You may not qualify if:

• Pregnant or breast-feeding women
• Failure to obtain written informed consent after a reflection 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Conditions

Carcinoma, Merkel Cell; Neoplastic Cells, Circulating

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Olivier Dereure, Pr

CONTACT

0467336906; o-dereure@chu-montpellier.fr

Angele Lallement, Dr

CONTACT

0649574139; angele.lallement@chu-montpellier.fr

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share