NCT05853783 Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
| NCT ID | NCT05853783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Proteocyte Diagnostics Inc. |
| Condition | Mouth Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2023-01-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.
Eligibility Criteria
Inclusion Criteria: * From the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system) * Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with: * No histological evidence of cancer with clinical follow-up data for a period of at least five years; or * OSCC development (histologic or documented evidence of invasive cancer). * Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center. Exclusion Criteria: * Patients with oral lesions or dysplasia with no indication of OSCC development or follow-up data of less than five years in non-OSCC patients. * Patients diagnosed with oral epithelial dysplasia concomitant with OSCC at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.
Contact & Investigator
Simon W Young, DDS, MD, PhD
PRINCIPAL INVESTIGATOR
UTHealthHouston
Frequently Asked Questions
Who can join the NCT05853783 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mouth Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05853783 currently recruiting?
Yes, NCT05853783 is actively recruiting participants. Contact the research team at Jody.Filkowski@medlior.com for enrollment information.
Where is the NCT05853783 trial being conducted?
This trial is being conducted at Birmingham, United States, Loma Linda, United States, Minneapolis, United States, Houston, United States and 1 additional location.
Who is sponsoring the NCT05853783 clinical trial?
NCT05853783 is sponsored by Proteocyte Diagnostics Inc.. The principal investigator is Simon W Young, DDS, MD, PhD at UTHealthHouston. The trial plans to enroll 180 participants.