NCT05687149 Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
| NCT ID | NCT05687149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Fanconi Anemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-03-23 |
| Primary Completion | 2035-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-03-23 with a primary completion date of 2035-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
* 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.
Contact & Investigator
Lisa J McReynolds, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT05687149 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 90 Years, studying Fanconi Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05687149 currently recruiting?
Yes, NCT05687149 is actively recruiting participants. Contact the research team at ncifamilystudyreferrals@mail.nih.gov for enrollment information.
Where is the NCT05687149 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05687149 clinical trial?
NCT05687149 is sponsored by National Cancer Institute (NCI). The principal investigator is Lisa J McReynolds, M.D. at National Cancer Institute (NCI). The trial plans to enroll 200 participants.