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| Name | Class |
|---|---|
| Rutgers University | OTHER |
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This project will evaluate the expression of a receptor called podoplanin (PDPN) in cells from oral cancers and precancerous lesions. We will also determine how sensitive oral cancer cells are to a potential drug called Maackia amurensis seed lectin (MASL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MASL treated | Experimental | Patients treated with lozenge containing MASL |
|
| Placebo treated | Placebo Comparator | Patients treated with lozenge without MASL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MASL | Drug | Patients treated with MASL lozenge |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-treatment OSCC Morphology and PDPN Expression | Measure morphology and podoplanin (PDPN) expression by immunohistochemistry of cells included in initial biopsies of oral lesions in comparison to normal oral squamous epithelial cells (OSCCs). We selected patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study. Intensity was graded on a scale of 1 to 5 with 5 having the most dysplastic morphology and highest PDPN expression. | 1 day. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-treatment OSCC Morphology and PDPN Expression | Evaluate and compare the PDPN expression and morphology of cells from included in resected oral lesions from patients treated with the experimental compound MASL or placebo. We will measure if MASL treatment decreases PDPN expression and normalizes morphology of OSCC cells on a defined scale of pathological examination by immunohistochemistry. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary S Goldberg | Rowan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Medical School | Newark | New Jersey | 07103 | United States | ||
| Rutgers School for Dental Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40681758 | Result | Yin AC, Holdcraft CJ, Helmig TJ, Brace EJ, Suster DI, Shienbaum AJ, Roden D, Kalyoussef E, Mir G, Capitle E, Baredes S, Shanti RM, Kaneko MK, Kato Y, Kobayashi H, Furusawa A, Fatahzadeh M, Goldberg GS. Effects of Maackia amurensis seed lectin (MASL) on OSCC cell morphology, PDPN expression, growth, and motility in a phase 1 clinical trial. J Cancer Res Clin Oncol. 2025 Jul 19;151(7):218. doi: 10.1007/s00432-025-06265-z. |
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18 subjects were consented and enrolled for consideration in this study. Of these, 8 subjects went on to the treatment phase of the study. Four of these 8 subjects were treated with MASL (experimental group) and four were treated with placebo (control group). The other 10 consented subjects were not considered for either MASL or placebo treatment, but their biological samples were still analyzed in the course of this study.
18 subjects were consented and enrolled for consideration in this study. Of these, 8 subjects went on to the treatment phase of the study. Four of these 8 subjects were treated with MASL (experimental group) and four were treated with placebo (control group). The other 10 consented subjects were not considered for either MASL or placebo treatment, but their biological samples were still analyzed in the course of this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | MASL Treated | Patients treated with lozenge containing MASL MASL: Patients treated with MASL lozenge |
| FG001 | Placebo Treated | Patients treated with lozenge without MASL Placebo: Patients treated with placebo lozenge |
| FG002 | Nontreated | Enrolled subject not treated with MASL or placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
OSCC cell morphology and PDPN expression were graded on a scale of 1 to 5.
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| ID | Title | Description |
|---|---|---|
| BG000 | MASL Treated | Patients treated with lozenge containing MASL MASL: Patients treated with MASL lozenge |
| BG001 | Placebo Treated | Patients treated with lozenge without MASL Placebo: Patients treated with placebo lozenge |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre-treatment OSCC Morphology and PDPN Expression | Measure morphology and podoplanin (PDPN) expression by immunohistochemistry of cells included in initial biopsies of oral lesions in comparison to normal oral squamous epithelial cells (OSCCs). We selected patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study. Intensity was graded on a scale of 1 to 5 with 5 having the most dysplastic morphology and highest PDPN expression. | Posted | Mean | Standard Error | score on a scale from 1 to 5 | 1 day. |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MASL Treated | Patients treated with lozenge containing MASL MASL: Patients treated with MASL lozenge |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary S. Goldberg | Rowan University | 8565666718 | gary.goldberg@rowan.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2023 | Sep 19, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 20, 2023 | Sep 19, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Placebo | Other | Patients treated with placebo lozenge |
|
| Newark |
| New Jersey |
| 07103 |
| United States |
| University Hospital | Newark | New Jersey | 07103 | United States |
| Rowan University | Stratford | New Jersey | 08084 | United States |
| BG002 | Nontreated | Patients not treated with MASL or placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Nontreated | Subjects not treated with MASL or placebo |
|
|
|
| Secondary | Post-treatment OSCC Morphology and PDPN Expression | Evaluate and compare the PDPN expression and morphology of cells from included in resected oral lesions from patients treated with the experimental compound MASL or placebo. We will measure if MASL treatment decreases PDPN expression and normalizes morphology of OSCC cells on a defined scale of pathological examination by immunohistochemistry. | Posted | Mean | Standard Error | score on a scale from 1 to 5 | 1 day |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo Treated | Patients treated with lozenge without MASL Placebo: Patients treated with placebo lozenge | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Nontreated | Subjects not treated with MASL or placebo. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|