An observational study in Oral Squamous Cell Carcinoma (OSCC) and OSCC, sponsored by Turku University Hospital. Enrolling by invitation at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Turku University Hospital · Observational
Among 10 studies in Squamous Cell Carcinoma of Head and Neck with a site in Finland — 3 open to participants now, 5 under way, 1 of them phase 3. Squamous Cell Carcinoma of Head and Neck · Finland.
Among the 10 studies in Squamous Cell Carcinoma of Head and Neck with a site in Finland, this one is the only one that started in 2026, is one of 4 observational ones, and was the 10th registered.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →3 of the 10 studies in Squamous Cell Carcinoma of Head and Neck with a site in Finland are open now. Recruiting first, the newest first:
Johnson & Johnson Enterprise Innovation Inc. · Sites in Finland, United States, Austria and 24 more countries
Ages 60+
Tampere University Hospital · Sites in Finland
Ages 40–90
A study can be open while its sites in Finland have not opened yet or have stopped. Only those recruiting at a site in Finland →
Of the 434 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 310 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 1
First in 2013; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 140 is above the median of 100 across 236 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 150 across the 6 interventional studies, 74 across the 4 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
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4 of 10 have an industry lead sponsor. The 7 most frequent:
Turku University Hospital is the lead sponsor of 288 studies on the registry; 68 are open to participants now.
Turku University Hospital has 4 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
1 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in Finland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05222932TILT Biotherapeutics Ltd.Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1 | 2026-12 |
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Among the 10 studies in Squamous Cell Carcinoma of Head and Neck with a site in Finland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, multicenter observational study evaluates LIMA1 immunohistochemistry (IHC) and histological depth of invasion (DOI) as prognostic biomarkers in adult patients with newly diagnosed oral squamous cell carcinoma (OSCC) undergoing curative-intent primary surgical treatment.
LIMA1 expression will be assessed in surgically resected primary tumor specimens by immunohistochemistry using antibody clone Thab2c, developed by Thestra Ltd and raised against LIMA1-alpha. LIMA1 IHC staining will be scored using a prespecified four-level scoring system from 0 to 3 and classified as LIMA1-low (scores 0-1) or LIMA1-high (scores 2-3). Histological DOI will be determined from hematoxylin and eosin (H\&E)-stained primary tumor specimens and classified as DOI-low (\<5 mm) or DOI-high (≥5 mm).
The primary objective is to determine whether adding LIMA1 IHC to DOI improves the identification of patients with a favorable disease-specific outcome after surgery alone compared with DOI alone. The primary analysis will focus on patients treated with curative-intent surgery without adjuvant radiotherapy or chemoradiotherapy. A disease-specific OSCC event is defined as local recurrence, new regional lymph node metastasis, distant metastasis, or death attributable to the index OSCC.
Clinical outcomes will be assessed at 2, 3, and 5 years. The study will also evaluate overall survival, OSCC recurrence-free survival, individual disease-specific OSCC events, and the technical evaluability and interobserver reproducibility of the Thab2c LIMA1 IHC assay. Study biomarker results will not affect patient treatment.
Oral squamous cell carcinoma (OSCC) is primarily treated with surgical resection, with adjuvant radiotherapy or chemoradiotherapy administered according to established clinicopathological risk factors. Some patients are successfully treated with surgery alone, whereas others develop recurrent or metastatic disease. Improved prognostic biomarkers are needed to identify patients for whom surgery alone is associated with a favorable disease-specific outcome.The present prospective, multicenter observational study will clinically validate Thab2c-based LIMA1 immunohistochemistry (IHC) and evaluate its prognostic performance, both independently and in combination with histological depth of invasion (DOI), in adult patients with newly diagnosed OSCC undergoing curative-intent primary surgical treatment. The study will enroll approximately 140 patients across all five Finnish university hospitals.
LIMA1 expression will be assessed by immunohistochemistry in formalin-fixed, paraffin-embedded primary tumor specimens using antibody clone Thab2c, developed by Thestra Ltd and raised against LIMA1-alpha. Staining will be evaluated using a prespecified four-level scoring system ranging from 0 to 3. LIMA1 IHC scores of 0-1 will be classified as LIMA1-low and scores of 2-3 as LIMA1-high. An inadequate specimen or technically unsuccessful assay will be classified as unevaluable and will not be assigned a staining score of 0. Histological DOI will be assessed from hematoxylin and eosin (H\&E)-stained sections of the primary OSCC specimen. DOI \<5 mm will be classified as DOI-low and DOI ≥5 mm as DOI-high. For the combined biomarker classification, the LIMA1/DOI low-risk group is defined as LIMA1 IHC score 0-1 and DOI \<5 mm. The LIMA1/DOI high-risk group is defined as LIMA1 IHC score 2-3 and/or DOI ≥5 mm. The primary objectives are to prospectively evaluate the prognostic performance of Thab2c-based LIMA1 IHC in identifying disease-specific OSCC events and to assess the prognostic performance of the combined LIMA1/DOI classification. In particular, the study will evaluate the ability of these biomarkers to identify patients at low or high risk of aggressive OSCC behavior, including local recurrence, regional lymph node metastasis, distant metastasis, and OSCC-specific death. The negative predictive value and sensitivity of the combined LIMA1/DOI classification will be assessed at prespecified follow-up time points. An additional objective is to determine whether adding LIMA1 IHC to DOI improves prognostic classification compared with DOI alone, particularly among patients treated with curative-intent surgery without adjuvant radiotherapy or chemoradiotherapy. This analysis will assess whether the combined LIMA1-low/DOI-low classification identifies a subgroup with more favorable disease-specific outcomes than the broader group classified as DOI-low on the basis of DOI \<5 mm alone. A disease-specific OSCC event is defined as the first occurrence of local recurrence of the index OSCC, new regional lymph node metastasis, distant metastasis, or death attributable to the index OSCC. Clinical outcomes will be assessed at 2, 3, and 5 years following primary surgery. Death attributable to causes other than the index OSCC will be treated as a competing event for disease-specific outcomes. Treatment-related deaths and deaths of uncertain cause will be treated as competing events in the primary disease-specific analysis. Prespecified sensitivity analyses will classify treatment-related deaths and deaths of uncertain cause as OSCC-specific deaths. Baseline clinical variables will include age, sex, smoking status, alcohol use, TNM classification, ICD diagnosis code, and anatomical location of the primary squamous cell carcinoma within the oral cavity.
The prognostic performance of LIMA1 IHC and the combined LIMA1/DOI classification will be evaluated in relation to disease-specific OSCC events. The prognostic performance of DOI alone (\<5 vs ≥5 mm) will also be compared with the combined LIMA1/DOI classification. Analyses will assess the ability of the combined classification to identify patients remaining free of disease-specific OSCC events, including those treated with surgery alone. Detailed statistical methods, including measures of prognostic performance and incremental prognostic value, will be prespecified in the statistical analysis plan before outcome analysis.
Exploratory Spatial Omics Analyses As an exploratory component of the study, spatial omics analyses may be performed on selected primary OSCC tumor specimens, subject to tissue availability and appropriate ethical and regulatory approvals. These analyses will investigate spatially resolved molecular and cellular characteristics of the tumor and its microenvironment, including features associated with LIMA1 expression, histological DOI, and aggressive clinical behavior. Spatially resolved molecular expression patterns, cellular composition, and tumor microenvironment characteristics may be compared between LIMA1-low and LIMA1-high tumors and between the prespecified combined LIMA1/DOI risk groups. Exploratory associations with clinical outcomes, including local recurrence, regional lymph node metastasis, distant metastasis, and OSCC-specific mortality, may also be investigated. These analyses are intended to provide additional biological and mechanistic insights into the relationship between LIMA1 expression, tumor invasiveness, and OSCC progression, and to generate hypotheses for future studies. The spatial omics component will not alter the prespecified primary outcome measures, planned sample size, or clinical management of study participants.
Assay Evaluation and Clinical Management The study will additionally assess the technical evaluability and interobserver reproducibility of the Thab2c LIMA1 IHC assay. IHC assessment will be performed without knowledge of clinical outcomes. Treating clinicians will remain blinded to study LIMA1 IHC results, and treatment decisions will be made according to routine clinical practice independently of the biomarker results. Spatial omics findings will likewise not influence clinical treatment decisions.
Patients with newly diagnosed oral squamous cell carcinoma who are planned to undergo curative-intent primary surgical treatment at participating Finnish university hospitals.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with newly diagnosed oral squamous cell carcinoma (OSCC) undergoing curative-intent primary surgical treatment. LIMA1 expression and histological depth of invasion (DOI) will be assessed in primary tumor specimens. Patients will be classified according to prespecified LIMA1 IHC and DOI categories for prognostic analyses. Study biomarker results will not influence treatment decisions.
Prognostic Performance of Thab2c-Based LIMA1 Immunohistochemistry for Disease-Specific OSCC Events
The primary outcome will prospectively evaluate the prognostic performance of Thab2c-based LIMA1 immunohistochemistry (IHC) for disease-specific OSCC events following curative-intent primary surgery. LIMA1 IHC will be classified as LIMA1-low (scores 0-1) or LIMA1-high (scores 2-3). A disease-specific OSCC event is defined as the first occurrence of local recurrence of the index OSCC, new regional lymph node metastasis, distant metastasis, or death attributable to the index OSCC. The occurrence of disease-specific OSCC events will be evaluated according to LIMA1 IHC classification at 2, 3, and 5 years to determine whether Thab2c-based LIMA1 IHC identifies patients at increased or decreased risk of aggressive OSCC behavior.
Time frame: From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years
Prognostic Performance of Combined LIMA1 IHC and DOI for Disease-Specific OSCC Events
The prognostic performance of the combined LIMA1 IHC and depth of invasion (DOI) classification will be evaluated for disease-specific OSCC events. The low-risk group is defined as LIMA1-low (IHC score 0-1) and DOI \<5 mm, and the high-risk group as LIMA1-high (IHC score 2-3) and/or DOI ≥5 mm. A disease-specific OSCC event is defined as the first occurrence of local recurrence of the index OSCC, new regional lymph node metastasis, distant metastasis, or death attributable to the index OSCC. Negative predictive value and sensitivity of the combined classification will be evaluated at 2, 3, and 5 years.
Time frame: 2, 3, and 5 years after primary surgery
Incremental Prognostic Value of LIMA1 IHC Added to DOI for Disease-Specific OSCC Events After Surgery Alone
This outcome will evaluate whether adding LIMA1 IHC to depth of invasion (DOI) improves prognostic classification for disease-specific OSCC events compared with DOI alone among patients treated with curative-intent surgery without adjuvant radiotherapy or chemoradiotherapy. Prognostic performance of DOI alone (\<5 vs ≥5 mm) will be compared with the combined LIMA1/DOI classification (low-risk: LIMA1 IHC 0-1 and DOI \<5 mm; high-risk: LIMA1 IHC 2-3 and/or DOI ≥5 mm). Incremental prognostic value will be assessed using prespecified measures of predictive performance.
Time frame: 2, 3, and 5 years after primary surgery
Overall Survival
Overall survival will be defined as the time from primary surgery to death from any cause. All deaths, including OSCC-specific deaths, treatment-related deaths, deaths from other causes, and deaths of uncertain cause, will constitute events. Patients without a recorded death will be censored at the last documented date alive or the applicable study data cut-off.
Time frame: From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years
Disease-Specific OSCC Event-Free Outcome According to LIMA1/DOI Classification
The cumulative incidence of the first disease-specific OSCC event and the corresponding disease-specific event-free probability will be estimated according to the prespecified LIMA1/DOI classification. A disease-specific OSCC event is defined as local recurrence of the index OSCC, new regional lymph node metastasis, distant metastasis, or death attributable to the index OSCC. Death from causes other than the index OSCC will be treated as a competing event. Estimates will be reported at 2, 3, and 5 years.
Time frame: From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years
OSCC-Specific Survival
OSCC-specific survival will be defined using death attributable to the index OSCC as the disease-specific event. Deaths attributable to other causes will be treated as competing events. Treatment-related deaths and deaths of uncertain cause will be treated as competing events in the primary analysis and as OSCC-specific deaths in prespecified sensitivity analyses. Cause of death will be determined using available clinical records, death certificates, and mortality-registry information where available, according to prespecified adjudication criteria.
Time frame: From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years
OSCC Recurrence-Free Survival
OSCC recurrence-free survival will be defined as the time from primary treatment to the first documented recurrence or metastatic progression of the index OSCC. A recurrence event is defined as local recurrence, new regional lymph node metastasis, or distant metastasis attributable to the index OSCC. Death without prior documented OSCC recurrence or metastasis will not constitute a recurrence event and will be treated as a competing event. Second primary malignancies will be recorded separately and will not constitute recurrence of the index OSCC.
Time frame: From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years
Local Recurrence of the Index OSCC
Occurrence of the first documented local recurrence of the index oral squamous cell carcinoma will be assessed during follow-up. Death without prior local recurrence will be treated as a competing event.
Time frame: From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years
Regional Lymph Node Metastasis of the Index OSCC
Occurrence of new regional lymph node metastasis attributable to the index OSCC will be assessed during follow-up. Death without prior regional lymph node metastasis will be treated as a competing event.
Time frame: From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years
Distant Metastasis of the Index OSCC
Occurrence of new distant metastasis attributable to the index OSCC will be assessed during follow-up. Death without prior distant metastasis will be treated as a competing event.
Time frame: From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years
Evaluability of the Thab2c LIMA1 Immunohistochemistry Assay
The proportion of primary OSCC tumor specimens yielding an evaluable Thab2c LIMA1 IHC result will be determined. An evaluable result is defined as a technically successful immunohistochemical staining result in a specimen meeting prespecified adequacy requirements and allowing assignment of a LIMA1 IHC score from 0 to 3. Inadequate specimens and technically unsuccessful assays will be classified as unevaluable and will not be assigned a score of 0.
Time frame: At pathological analysis of the primary surgical tumor specimen
Interobserver Reproducibility of Thab2c LIMA1 Immunohistochemistry
Interobserver agreement in the assessment of Thab2c LIMA1 IHC staining will be evaluated between pathologists using both the prespecified four-level staining score (0-3) and the binary LIMA1-low (scores 0-1) versus LIMA1-high (scores 2-3) classification.
Time frame: At pathological analysis of the primary surgical tumor specimen
Spatially Resolved Molecular and Cellular Features According to LIMA1 Expression and DOI Classification
Exploratory spatial omics analyses will be performed on a subset of available primary OSCC tumor specimens to characterize spatially resolved molecular expression patterns, cellular composition, and tumor microenvironment features. Quantitative spatial omics measurements will be compared across prespecified LIMA1 IHC and DOI classifications, and exploratory associations with disease-specific OSCC events will be investigated. The analyses will be hypothesis-generating and will not affect clinical management.
Time frame: At exploratory molecular analysis of primary surgical tumor specimens; associations with clinical outcomes assessed through 2, 3 and 5 years after primary surgery.
Plan to share: No — Individual participant data (IPD) are not planned to be made publicly available due to patient privacy and data protection requirements. Requests for access to de-identified study data for scientifically justified research purposes may be considered by the study investigators and the data controller on a case-by-case basis, subject to applicable ethical, legal, institutional, and data protection requirements.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2031, 62 months later.
Of 108 non-industry observational studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 132. This study's planned 62 months is below that.
Counting every sponsor, half of 118 studies reached it within 81 months; a quarter within 29 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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