Study of HLA-DR in Cell Cultures Isolated From Primary Squamous Cell Carcinoma

NCT06041464 | Unknown

• 1 other identifier: 3740
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

In our previous study (title: Expression of Major Histocompatibility Complex Molecules class II- HLA-DR in Squamous Cell Carcinoma of the Head and Neck. ID 2222)the Authors verified that the epithelial cells of squamous cell carcinoma of the head and neck acquire the ability to express HLA-DR. Although the role of the expression of these molecules on neoplastic cells still remains controversial, a positive association between HLA-DR expression and clinical outcome was observed by us in analogy to what was reported by several studies on various types of tumors : in squamous cell carcinoma of the larynx, colorectal cancer , stomach cancer and others. In these tumors the expression of HLA-DR correlates with the presence of immune cells such as CD16+/CD11c macrophage myeloid cells, associated with a good prognosis and T cells which, recalled in the damaged tissue, they determine the formation of an immunogenic microenvironment that could support an anti-tumor immune response. Oncology studies are in fact focusing on the role of the tumor microenvironment which is characterized by different cell populations, among which the most abundant population is represented by tumor-associated fibroblasts (CAF). CAFs are fibroblasts which, in a tumor context, assume a phenotype similar to that of myo-fibroblasts and are distinguishable from normal fibroblasts by a greater expression of α-sma, FAP and FSP-1, which represent their specific markers, as well as a greater expression of vimentin, fibronectin, and type XI collagen. Numerous evidences in different types of tumors have reported both the immunosuppressive role, as these cells are capable in vitro of inhibiting the proliferation of T lymphocytes, to favor their apoptosis or to induce the phenotype of regulatory T lymphocytes; and the pro-tumor role, as they are capable of promoting tumor proliferation and invasion, angiogenesis and metastasis, thus contributing to the worsening of the prognosis. Many studies are directing their research on which factors secreted by CAFs are responsible for their function. In particular, among the many factors secreted by CAFs, there are the interleukins IL-17 and IL-33 which, as it has been demonstrated, can induce the activation of HLA-DR molecules on bone marrow-derived mesenchymal cells . It therefore seems interesting to investigate the role of HLA-DR in relation to the presence of the tumor microenvironment represented by CAFs.

Conditions

Squamous Cell Carcinoma of the Head and Neck; Cancer

Keywords

HEAD AND NECK; CANCER; IMMUNOLOGY

Outcome Measures

Primary Outcomes (2)

• NUMBER OF FLASKS OF HUMAN HEALTHY TISSUE CELL CULTURE FROM THE HEALTHY HEALTHY BIOPSY BIOPSY

  FROM THE DATA OF HEALTHY EPITHELIAL CELLS AND FIBROBLASTS BIOPSY UNTIL THE DATE OF CELL COLTURE ISOLATION ASSESSED UP TO 4 WEEKS

• NUMBER OF FLASKS OF TUMOR ASSOCIATED EPITHELIAL CELL AND FIBROBLASTS ASSOCIATED CANCER CULTURE FROM TUMOR BIOPSY

  FROM THE DATA OF TUMOR EPITHELIAL CELLS AND FIBROBLASTS BIOPSY UNTIL THE DATE OF CELL COLTURE ISOLATION ASSESSED UP TO 4 WEEKS

Secondary Outcomes (2)

• ZERO UP TO 4 SCALE (NEGATIVE UP TO VERY INTENSIVE) IMMUNOHISTOCHEMICAL HLA-DR POSITIVITY IN HEALTHY EPITELIAL CELLS AND FIBROBLASTS CULTURES

  FROM LAST ENROLLED PATIENT CELL COLTURES ISOLATION UP TO 16 WEEKS

• ZERO UP TO 4 SCALE (NEGATIVE UP TO VERY INTENSIVE) IMMUNOHISTOCHEMICAL HLA-DR POSITIVITY IN TUMOR EPITELIAL CELLS AND FIBROBLASTS CULTURES

  FROM LAST ENROLLED PATIENT CELL COLTURES ISOLATION UP TO 16 WEEKS

Study Arms (2)

cancer epithelial cell

cancer epithelial cells culture

Other: cell culture

cancer fibroblast culture

cancer fibroblast cells culture

Other: cell culture

Interventions

cell culture OTHER

isolation of cell culture

Also known as: immunohistochemical detection

cancer epithelial cell; cancer fibroblast culture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The calculation of the sample size was carried out using Power Analysis, deeming acceptable a first type error equal to 5% with a test power of 90%, therefore a second type error of 10%. patients Four patients with primary squamous cell carcinoma of the head and neck admitted for surgical treatment at the Otolaryngology Clinic, Fondazione Policlinico Gemelli, IRCCS, Rome, in the year 2020-2021 will be included in the study. Of the 4 cases considered will be available: * Clinical data * Informed consent * Tumor tissue sample * Non-tumor tissue sample taken from material surgically removed during surgery

You may qualify if:

• diagnosis of primary squamous cell carcinoma of the head and neck, 2) signing of informed consent for study involvement.

You may not qualify if:

• \) patients diagnosed with non-primary squamous cell carcinoma of the head and neck and already undergoing radiotherapy, chemotherapy and immunotherapy, biological therapy.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Gemelli, Irccs

Rome, Lazio, 00168, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Epithelial cells from healthy biopsy and tumor epithelial cells from tumor biopsy maintained in culture with: DMEM High Glucose + HAM'S F12 1:1, FBS 10%, penicillin-streptomycin 1%, L-glutamine 1%, insulin 10µg /ml, EGF 20ng/ml, Hydrocortisone 0.5µg/ml; • Fibroblasts from healthy biopsy and tumor associated fibroblasts (CAF) from tumor biopsy maintained in culture with: DMEM High Glucose, FBS 10%, penicillin-streptomycin 1%, L-glutamine 1%. Both fibroblasts and CAFs will be isolated from epithelial and tumor cell cultures, respectively, with a series of passages in trypsin-EDTA 0.25%

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasms

Interventions

Cell Culture Techniques

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Culture Techniques; In Vitro Techniques

Study Officials

• gabriella cadoni, Prof

  FONDAZIONE POLICLINICO UNIVERSITARIO GEMELLI, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: September 18, 2023
• Study Start: March 2, 2021
• Primary Completion: October 2, 2023
• Study Completion: March 2, 2024
• Last Updated: September 18, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)