RECRUITING

Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia

Quick Facts

Study Start:2023-03-23
Study Completion:2035-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05687149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Individuals with prior cancer diagnosis are eligible.
  3. 3. Individuals from other countries are eligible provided they can travel to the USA on their own.
  4. 4. Ability to understand and/or the willingness of the individual, parent, LAR, or minor s legal guardian to provide informed consent.
  1. 1. Referred individuals for whom reported diagnosis of FA cannot be verified.
  2. 2. Inability of the individual, parent, LAR, or legal guardian to understand and be willing to sign a written informed consent document.

Contacts and Locations

Study Contact

NCI Family Study Referrals
CONTACT
(800) 518-8474
ncifamilystudyreferrals@mail.nih.gov
Neelam Giri, M.D.
CONTACT
(240) 276-7256
girin@mail.nih.gov

Principal Investigator

Neelam Giri, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Neelam Giri, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-23
Study Completion Date2035-12-31

Study Record Updates

Study Start Date2023-03-23
Study Completion Date2035-12-31

Terms related to this study

Keywords Provided by Researchers

  • Hereditary
  • Inherited Bone Marrow Failure Syndrome
  • Oral Potentially Malignant Lesion
  • Surveillance
  • Precancer

Additional Relevant MeSH Terms

  • Fanconi Anemia
  • Inherited Bone Marrow Failure Syndrome