Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™ (NCT05853783) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
United States180 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.