Retrospective intratumoral identification of bacterial species in oral squamous cell carcinoma and immunohistochemical and molecular biological characterization

Retrospective intratumoral identification of bacterial species in oral squamous cell carcinoma and immunohistochemical and molecular biological characterization - ImmunE FusOS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039066

Enrollment

200

Registered

2026-01-22

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant neoplasm of other and unspecified parts of the tongue, gingiva, base of tongue, and floor of the mouth (C01–C04)

Interventions

Group 1: Retrospective analysis of 200 patients who underwent oncological resection of an oral squamous cell carcinoma between 2010 and 2023.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Voluntary consent and written signing of the informed consent form. Surgical treatment in the Department of Oral and Maxillofacial Surgery at the University Medical Center Freiburg for an oral squamous cell carcinoma between 2010 and 2023, including deceased patients. Tumor follow-up at the Department of Oral and Maxillofacial Surgery with longitudinal data of at least 3 years. Availability of archived tumor material that can be used for research purposes.

Exclusion criteria

Exclusion criteria: Refusal to participate in the study. Patients with incomplete information on post-therapeutic follow-up. Other tumor diseases or secondary malignancies. Patients whose primary tumor was surgically treated at a different location.

Design outcomes

Primary

Measure	Time frame
Retrospective identification and quantification of intracellular bacterial species in formalin-fixed, paraffin-embedded tissue samples of OSCC via qPCR/metagenomics, with stratification of tumors according to infection status. Immunohistochemical analysis of immune cell and stromal cell populations in the tumor and tumor microenvironment. Exploratory proteomic characterization of the tumors using mass spectrometry to investigate the relationships between bacterial colonization, tumor biology, and immune responses.	—

Measure

Time frame

Retrospective identification and quantification of intracellular bacterial species in formalin-fixed, paraffin-embedded tissue samples of OSCC via qPCR/metagenomics, with stratification of tumors according to infection status. Immunohistochemical analysis of immune cell and stromal cell populations in the tumor and tumor microenvironment. Exploratory proteomic characterization of the tumors using mass spectrometry to investigate the relationships between bacterial colonization, tumor biology, and immune responses.

—

Secondary

Measure	Time frame
Correlation of clinical data with immunological and molecular biological findings. Detection and characterization of bacterial species in lymph node metastases. Immunohistochemical and proteomic analysis of lymph node metastases analogous to the analyses performed on primary tumors.	—

Countries

Germany

Contacts

Public ContactTim Halstenbach, Dr. Marietta Wolf

Universitätsklinikum Freiburg

marietta.wolf@uniklinik-freiburg.de+4976127049100

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026