Immunomonitoring of Circulating Immune Cells in Maxillofacial Surgery

NCT07772063 | Not Yet Recruiting

• 1 other identifier: APHP260559
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The immune response following facial reconstruction may help predict healing time and the date of discharge after maxillofacial surgery. Regulatory T cells (Tregs) are emerging as powerful modulators of the immune response in various contexts during reconstruction. Indeed, Tregs are involved in tissue regeneration, control the local inflammatory response, and promote effective tissue repair while limiting fibrosis. An early increase in circulating Tregs could serve as an indicator of a favorable reparative/regenerative response. Primary objective: To identify changes in the proportion of regulatory T cells (Tregs) among circulating immune cells between the preoperative and postoperative periods, and to assess its association with length of hospital stay. Primary outcome measure: proportion of regulatory T cells (Tregs) among CD4 lymphocytes, measured by flow cytometry at different time points (preoperative, perioperative, and postoperative), and its association with length of hospital stay (days). Study Design: monocentric, including a maximum of 60 patients; Inclusion criteria: Age ≥ 18 years; managed in the department of maxillofacial surgery (Pitié-Salpêtrière Hospital); Scheduled for surgery as part of treatment involving free flap reconstruction; Informed about the study, with no objections, and having provided written consent for genetic testing Exclusion criteria: Pregnant or breastfeeding women; Individuals under legal protective measures Research Process: After verifying eligibility criteria, patients will be informed about the study during a clinical visit. Following a reflection period that the patient deems necessary to make a decision, their lack of objection and consent to genetic testing will be obtained. As part of the research, a 7 mL tube of ACD blood will be collected in addition to the routine blood samples during routine blood draws at the following visits: preoperative, perioperative (during surgery), and postoperative follow-ups (Day 2, Day 5, and Day 15). These tubes will then be analyzed in the Immunology Research Laboratory of Prof. Miyara and Dr. Bouaoud (CIMI, Pitié Salpêtrière) using flow cytometry (counting/assay of Tregs and subpopulations). During the operation, surgical waste (bone, muscle, drainage fluids) will also be collected for research purposes; it will be analyzed in the immunology research laboratory of Prof. Miyara and Dr. Bouaoud (CIMI, Pitié Salpêtrière) using flow cytometry and, in some cases, single-cell transcriptomics when the sample meets the necessary quality criteria (sufficient cell count, viability, etc.).

Conditions

Head and Neck Cancer (H&N); Trauma Sequelae; Osteoradionecrosis of Jaws

Keywords

Immunomonitoring of Circulating Immune; Cells Following Free Flap Reconstruction in Maxillofacial Surgery

Outcome Measures

Primary Outcomes (1)

• Tregs proportion

  Proportion of regulatory T cells (Tregs) among CD4 lymphocytes, measured by flow cytometry at different time points (preoperative, perioperative, and postoperative), and association with length of hospital stay (days).

  preoperative (Day -1), perioperative (Day 0), and postoperative (Day 2, Day 7, Day 15, Day of discharge)

Secondary Outcomes (2)

• Tregs kinetics and surgical wound

  preoperative (Day -1), perioperative (Day 0), and postoperative (Day 2, Day 7, Day 15, Day of discharge)

• Tregs kinetics and patient discharge

  preoperative (Day -1), perioperative (Day 0), and postoperative (Day 2, Day 7, Day 15, Day of discharge)

Interventions

Treg OTHER

A 7-mL tube of ACD blood will be collected in addition to the routine blood draw tubes during routine blood draws at the following visits: preoperative, perioperative (during surgery), and postoperative follow-ups (Day 2, Day 5, and Day 15). These tubes will then be analyzed in the Immunology Research Laboratory of Prof. Miyara and Dr. Bouaoud (CIMI, Pitié-Salpêtrière) using flow cytometry (counting and quantifying Tregs and subpopulations). Translated with DeepL.com (free version)

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 admitted to the Maxillofacial Surgery Department for a scheduled procedure involving free flap reconstruction.

You may qualify if:

• Age ≥ 18 years
• managed in the department of maxillofacial surgery (Pitié-Salpêtrière Hospital)
• Scheduled for surgery as part of treatment involving free flap reconstruction
• Informed about the study, with no objections, and having provided written consent for genetic testing

You may not qualify if:

• Pregnant or breastfeeding women
• Individuals under legal protective measures

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• CIMI: collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Jebrane BOUAOUD, Associate Professor, MD PhD

CONTACT

01 42 17 82 91; jebrane.bouaoud@aphp.fr

Makoto MIYARA, MD PhD

CONTACT

01 42 17 84 91; makoto.miyara@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.