Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-90
SponsorNational Cancer Institute (NCI)
About this trial
Background:
Fanconi anemia (FA) is an inherited disorder. People with FA are more likely to get certain cancers, especially squamous cell carcinoma (SCC). These cancers usually appear first in the mouth, esophagus, and genital and anal areas. Early detection of SCCs may help improve survival rates for people with FA.
Objective:
This natural history study will regularly screen people with FA for SCC.
Eligibility:
People aged 12 years and older with FA or a prior cancer diagnosis. Children aged 8 to 11 years with FA may also be eligible.
Design:
Participants will receive a comprehensive screening for cancer or early signs of cancer.
Participants will have a physical exam. They will provide blood and saliva samples. Cells will be collected by rubbing a swab on the inside of the cheeks. A skin sample may be removed from the back, buttocks, or inside of the upper arm.
Participants will have pictures taken of their mouth. Any mouth sores will be mapped. Cells will be collected from the sores with a small brush.
Specialists will examine the participant s ears, nose, throat, teeth, and skin.
Adult participants may have a gastrointestinal exam or pelvic exam. Participants may have an endoscopy. A long tube with a camera and a light will be inserted through the mouth and down into the stomach.
Participants may have a liver ultrasound. A wand will be pressed against their belly to get pictures of the organs inside the body.
Participants will have screenings every year for up to 10 years. Each visit will last up to 3 days. They will have remote follow-up visits every 6 - 8 months....
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Individuals with prior cancer diagnosis are eligible.
Individuals from other countries are eligible provided they can travel to the USA on their own.
Ability to understand and/or the willingness of the individual, parent, LAR, or minor s legal guardian to provide informed consent.
Disqualifiers
Referred individuals for whom reported diagnosis of FA cannot be verified.
Inability of the individual, parent, LAR, or legal guardian to understand and be willing to sign a written informed consent document.
Trial population
Persons \>=12 years with FA primarily from North America will be included in the study. Persons \< 12 years can also be included if they have a history of persistent oral potentially malignant lesions, dysphagia, or other concerning symptoms. Persons with FA from other countries are eligible provided they can travel to USA on their own.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Fanconi anemia
Trial outcomes
Primary outcomes
1
Screen Patients with FA
Prospectively screen individuals with FA for early indicators for the development of esophageal and anogenital SCC.
Time frame
ongoing2
Clinical and Pathological Natural History of Oral Potentially Malignant Lesion
Characterize the clinical and pathological natural history of OPMLs in AYAs with FA using brush biopsies for cytopathologic diagnosis and aneuploidy and correlate those findings with tissue biopsies and genomic analyses of oral epithelial dysplasia (OED) and SCC.
Time frame
ongoing3
Cohort of Patients with FA
A prospective cohort of individuals with Fanconi anemia (FA) at very high risk of squamous cell carcinoma (SCC)
Time frame
ongoingSponsors and contacts
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Source ClinicalTrials.gov