LIMA1 Immunohistochemistry and Depth of Invasion as Prognostic Biomarkers in Oral Squamous Cell Carcinoma
NCT07934316, Enrolling by invitation, Turku University Hospital
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | LIMA1 Immunohistochemistry and Depth of Invasion as Prognostic Biomarkers in Oral Squamous Cell Carcinoma | ClinicalTrials.gov |
| NCT number | NCT07934316 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Enrollment | 140 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Turku University Hospital | ClinicalTrials.gov |
| Conditions | Oral Squamous Cell Carcinoma (OSCC), OSCC | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Prognostic Performance of Thab2c-Based LIMA1 Immunohistochemistry for Disease-Specific OSCC Events | From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years | 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. | ClinicalTrials.gov |
| Primary | Prognostic Performance of Combined LIMA1 IHC and DOI for Disease-Specific OSCC Events | 2, 3, and 5 years after primary surgery | 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. | ClinicalTrials.gov |
| Secondary | Incremental Prognostic Value of LIMA1 IHC Added to DOI for Disease-Specific OSCC Events After Surgery Alone | 2, 3, and 5 years after primary surgery | 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. | ClinicalTrials.gov |
| Secondary | Overall Survival | From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years | 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. | ClinicalTrials.gov |
| Secondary | Disease-Specific OSCC Event-Free Outcome According to LIMA1/DOI Classification | From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years | 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. | ClinicalTrials.gov |
| Secondary | OSCC-Specific Survival | From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years | 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. | ClinicalTrials.gov |
| Secondary | OSCC Recurrence-Free Survival | From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years | 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. | ClinicalTrials.gov |
| Secondary | Local Recurrence of the Index OSCC | From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years | 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. | ClinicalTrials.gov |
| Secondary | Regional Lymph Node Metastasis of the Index OSCC | From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years | 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. | ClinicalTrials.gov |
| Secondary | Distant Metastasis of the Index OSCC | From primary surgery through 5 years of follow-up, with outcomes assessed at 2, 3, and 5 years | 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. | ClinicalTrials.gov |
| Secondary | Evaluability of the Thab2c LIMA1 Immunohistochemistry Assay | At pathological analysis of the primary surgical tumor specimen | 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. | ClinicalTrials.gov |
| Secondary | Interobserver Reproducibility of Thab2c LIMA1 Immunohistochemistry | At pathological analysis of the primary surgical tumor specimen | 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. | ClinicalTrials.gov |
| Other | Spatially Resolved Molecular and Cellular Features According to LIMA1 Expression and DOI Classification | At exploratory molecular analysis of primary surgical tumor specimens; associations with clinical outcomes assessed through 2, 3 and 5 years after primary surgery. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
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Participant flow 0
How many started, completed or left each group, period by period.
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
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Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
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Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)