A Phase 1 interventional study of 5-fluorouracil in Oral Leukoplakia, sponsored by University of California, San Francisco. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-22.
Sponsored by University of California, San Francisco · Phase 1, Interventional, and Treatment
Among 20 studies in Leukoplakia, Oral with a site in United States — 1 open to participants now, 3 under way, none of them phase 3. Leukoplakia, Oral · United States.
Among the 20 studies in Leukoplakia, Oral with a site in United States, this one is the 14th largest by enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2022, is one of 4 in phase 1, and was the 18th registered.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
Browse Leukoplakia, Oral studies →1 of the 20 studies in Leukoplakia, Oral with a site in United States is open now. Recruiting first, the newest first:
University of Minnesota · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 7 Leukoplakia, Oral studies recruiting now, 5 set no upper age limit and none stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 2 started in 2022.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 26 across the 15 interventional studies, 487 across the 2 observational. Of the 15 that completed or were terminated, 6 (40%) have results posted.
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4 of 20 have an industry lead sponsor. The 10 most frequent:
University of California, San Francisco is the lead sponsor of 2,170 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
University of California, San Francisco has 1 study filed under Leukoplakia, Oral — fewer than ten, so there is no comparison to draw.
1 of the studies in Leukoplakia, Oral with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05727761University of MinnesotaPioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia | 2027-07-30 |
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Among the 20 studies in Leukoplakia, Oral with a site in United States, from their registry updates:
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This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).
PRIMARY OBJECTIVE:
I. Evaluate the feasibility of intralesional 5-fluorouracil (5-FU) injection for the treatment of oral leukoplakia
SECONDARY OBJECTIVE:
I. Evaluate the safety profile and side effects of the study drug.
OUTLINE:
Participants diagnosed with OL will receive multiple intralesional injections of 5-FU solution over a maximum period of 6 weeks, followed by a follow-up visit after 3 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive up to 3 intralesional 5-fluorouracil injections (0.25 mL of a 50mg/mL solution) once every 2 weeks into an oral leukoplakia lesion.
Drug: 5-fluorouracil
Given intralesionally by injection
Also known as: 5FU
Proportion of participants s who complete 5-FU injections
The number of participants who completed the full course of 3 intralesional injections will be compared to the overall total of participants. If the the mucosa becomes ulcerated or participants are unable/unwilling to continue with therapy, 5FU injections will be stopped.
Time frame: Up to 6 weeks
Number of participants with treatment-related adverse events
The number of participants with documented treatment-related adverse events classified by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported
Time frame: Up to 3 months
Change in area of clinically visible oral leukoplakia lesions
The total change in area (measured to nearest millimeter (mm) of clinically visible oral leukoplakia lesion will be defined by the product of the two largest perpendicular measurements. The two largest perpendicular measurements of the treated oral leukoplakia lesion will be measured and multiplied to calculate the lesion area at baseline and again at 3 months.
Time frame: Up to 3 months
Proportion of participants with a change in histologic grade
A board-certified oral and maxillofacial pathologist will review biopsy specimens obtained from the treated oral leukoplakia before and after treatment with 5FU and determine change in histologic grade from baseline.
Time frame: Up to 3 months
Change in scores on the oral mucosal diseases quality of life questionnaire (COMD-QLQ)
The oral mucosal diseases quality of life questionnaire (COMD-QLQ) is a validated instrument that will assesses the effect that oral leukoplakia has on participants' daily life activities before and after 5-FU intralesional therapy. The survey consists of 24 questions with five response options per item. The response for each item is coded from 0 to 4 with "not at all=0" and "extremely=4" (at time of scoring, for 3 questions, the Likert scale is reversed). The summary of the overall score ranges from 0 to 104, with a higher score indicating a poorer patient-assessed quality of life score.
Time frame: Up to 3 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2022; primary completion for Aug 2023, 11 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluorouracil
University of California, San Francisco →