Understanding Squamous Cell Carcinoma in People with Fanconi Anemia
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
This study looks at how squamous cell carcinoma develops in people with Fanconi anemia to help catch it early and improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 8 Years to 90 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05687149 on ClinicalTrials.gov |
What this trial studies
This observational study aims to define the natural history of squamous cell carcinoma (SCC) in individuals with Fanconi anemia (FA) by conducting regular screenings. Participants aged 12 years and older, or 8 to 11 years with specific symptoms, will undergo comprehensive evaluations, including physical exams, biospecimen collection, and mapping of oral lesions. The study will focus on identifying early indicators of cancer development and understanding the underlying mechanisms of tumorigenesis in this high-risk population. By gathering detailed clinical and pathological data, the study seeks to improve early detection and management of SCC in individuals with FA.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 years and older with a diagnosis of Fanconi anemia, or those aged 8 to 11 with concerning symptoms.
Not a fit: Patients without a verified diagnosis of Fanconi anemia or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and treatment strategies for squamous cell carcinoma in patients with Fanconi anemia.
How similar studies have performed: While this study focuses on a specific population, similar approaches in cancer surveillance have shown promise in improving outcomes for high-risk groups.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: 1. On referral, persons \>= 12 years with FA primarily from North America will be included. An individual with FA who is 8 - 11 years can also be included if they have a history of persistent OPMLs, dysphagia, or other concerning symptoms. 2. Individuals with prior cancer diagnosis are eligible. 3. Individuals from other countries are eligible provided they can travel to the USA on their own. 4. Ability to understand and/or the willingness of the individual, parent, LAR, or minor s legal guardian to provide informed consent. EXCLUSION CRITERIA: 1. Referred individuals for whom reported diagnosis of FA cannot be verified. 2. Inability of the individual, parent, LAR, or legal guardian to understand and be willing to sign a written informed consent document.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Lisa J McReynolds, M.D. — National Cancer Institute (NCI)
- Study coordinator: NCI Family Study Referrals
- Email: ncifamilystudyreferrals@mail.nih.gov
- Phone: (800) 518-8474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.