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Search / Trial NCT05687149

Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jan 17, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

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

ClinConnect Summary

This clinical trial is focused on understanding the risk of squamous cell carcinoma (SCC) in people with Fanconi anemia (FA), a genetic condition that can lead to bone marrow failure and increases the chance of certain cancers. The main goal is to regularly screen individuals with FA for early signs of SCC, which often appears in areas like the mouth and throat. By catching these cancers early, the hope is to improve survival rates for those affected by FA.

To participate, you need to be at least 12 years old and have a diagnosis of FA, or you may qualify if you're 8 to 11 years old with specific symptoms. Participants will undergo comprehensive screenings that include physical exams, blood tests, and various imaging tests, happening once a year for up to 10 years. Each visit could last up to three days, and there will also be follow-up visits every six to eight months. This study aims to help doctors understand how SCC develops in people with FA, which could lead to better treatments and care in the future.

Gender

ALL

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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Neelam Giri, M.D.

Principal Investigator

National Cancer Institute (NCI)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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