Trial · NCT07901959
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety | For the duration of the study, 22 months for each individual participant | The investigators will assess the primary outcome of safety and tolerability of metformin and naproxen as chemoprevention agents for head and neck squamous cell carcinoma in Fanconi anemia patients: Incidence of Grade 2 or Higher Intervention-Related Adverse Events (AEs) Description: The number and percentage of participants experiencing at least one grade ≥2 AE judged to be related to study intervention (as per CTCAE v5.0 criteria). Investigators will compare the proportion of adverse events for pre-intervention vs. metformin and pre-intervention vs. naproxen. Time Frame: Throughout the drug intervention period and up to 30 days after last intervention dose. Assessment Methods: Investigator assessment at clinic visits, participant self-reports, and clinical laboratory evaluations. Safety Goal: \<5% of participants experiencing Grade ≥3 drug-related AEs. |
| Primary | Tolerability of Intervention Regimen | Duration of intervention, from month 3 to month 16 of the study for each participant. | Defined as participant retention and ability to continue intervention without dose-limiting toxicities, treatment discontinuation, or withdrawal due to side effects. Investigators will report proportion of dropout during each intervention. |
| Secondary | Frequency of Any Adverse Events (All Grades) | Baseline visit through end of study, a weekly survey will assess AEs. Participants can report AEs to designated study staff at any point during the duration of the study, | Count and categorization of all reported AEs, regardless of severity or attribution. The investigators will report proportion of participant with AEs attributed to drug, subcategorized by intervention during which AE occurred and AE grade. |
| Secondary | Adherence to Intervention Regimen (Pill Counts and participant report) | Pill counts will occur at the 9 month and 16 month site visits. Participant adherence self-report surveys will be collected at the 9 month and 16 month site visits. | Proportion of prescribed doses taken, measured via pill count and participant report via survey checklist. |
| Secondary | Self-Reported Adherence and Symptom Tracking | Weekly for the duration of the study. | Participant-reported adherence, side effects, and symptoms logged weekly through electronic survey tools. |
| Secondary | Self-Exam Completion Rate (via FAexam App) | Monthly for the duration of the study. | Proportion of expected monthly oral exams completed by participants using the secure FAexam app. |
| Secondary | New oral lesions | At each site visit (baseline, 3 month, 9 month, 16 month and 22 month) for the duration of the study. | The investigators will record and compare the change in lesion number and size for participants between the start and end of the intervention period compared to between the start and end of the preintervention period. Assessment methods: Lesion status will be assessed at each study visit through oral examination, lesion mapping and measurement, and standardized, non-identifying oral cavity imaging. Comparisons will be made between pre-intervention vs after metformin, and between preintervention vs after naproxen. The investigators will compare the mean number of lesions in each time period across intervention groups. |
| Secondary | Target Lesion Histological Grade | At each site visit (baseline, 3 month, 9 month, 16 month and 22 month) for the duration of the study. | Histological grading (e.g., normal, hyperplasia, dysplasia, carcinoma in situ) from a target lesion selected based on clinical features at: 1. end of pre-intervention period (3-month visit) and compared to follow up biopsy at end of first intervention period (9-months). 2. end of first intervention period (9-month visit) will be compared to subsequent follow up biopsy at end of second intervention period (16-months). 3. end of second intervention period (16-month visit) will be compared to subsequent follow up biopsy at end of study (22-months). Histologic changes in that lesion will be evaluated by a trained pathologist and used to assess response to intervention. The investigators will compare the mean number of lesions in each grade category in each time period across intervention groups. |
| Other | Presence of Pathogenic TP53 Variants (Oral Brush Samples) (Exploratory) | Brush samples will be collected at each site visit (baseline, 3 month, 9 month, 16 month and 22 month) for the duration of the study. | Binary variable (presence/absence) indicating whether pathogenic or likely pathogenic somatic TP53 variants are detected in oral brush samples. Somatic origin will be deduced by presence of the same variant in all tested oral sites and if necessary, confirmed by comparing results to matched germline DNA (blood or skin). The presence of TP53 variants will be tracked longitudinally and compared across timepoints pre- and post-intervention. |
| Other | Presence of Copy Number Variants (CNVs) in Oral Brush Samples (Exploratory) | Brush samples will be collected at each site visit (baseline, 3 month, 9 month, 16 month and 22 month) for the duration of the study. | Binary variable indicating detection of CNVs via genome-wide SNP genotyping. The presence of CNVs will be tracked longitudinally and compared across timepoints pre- and post-intervention. Brushing will be performed at each study visit. |
| Other | Presence of Somatic Mutations by Duplex Sequencing (NanoSeq) (Exploratory) | NanoSeq samples will be collected by buccal swab at each site visit (baseline, 3 month, 9month, 16 month and 22 month) for the duration of the study. | Binary and quantitative variables indicating somatic mutation burden (e.g., number of variants, variant allele frequency) from buccal swab samples assessed via NanoSeq 18. Changes over time will be compared between baseline and post-metformin/naproxen intervention. |
| Other | Histologic and Molecular Biomarker Changes in Target Lesion (Exploratory) | Assessment of biopsy samples will occur following site visits during which an oral biopsy was obtained, for the duration of the study. This may occur at each site visit except the baseline (3 month, 9month, 16 month and 22 month visits). | Exploratory variable assessing protein expression changes via immunohistochemistry (IHC) in biopsied tissue. Specific markers (included but not limited to Ki67 a proliferative marker, pS6 a marker of mTOR pathway activity, and COX-2 a measure of pathway activity) will be used to infer molecular mechanisms of action of metformin and naproxen. DNA and RNA sequencing may also be performed to identify changes including TP53 mutations and copy number variants or gene expression profiles in the lesion tissue. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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