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Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 345 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Re-verified, no change to tracked fields
  4. Study description expanded, about 14 words Eligibility criteria expanded, about 3 words Show all 2 changesShow less
    • Eligibility criteria expanded, about 3 words
  5. 4 versions Re-verified since Jun 16, 2026, no change to tracked fieldsv338-v341
Show 42 earlier versionsHide 42 earlier versions
  1. Eligibility criteria shortened, about 11 words Study description expanded, about 33 wordsv337 Show all 2 changesShow less
    • Study description expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  2. 20 versions Re-verified since Jul 10, 2025, no change to tracked fieldsv317-v336
  3. Eligibility criteria revisedv316 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  4. Study Status, Study Description, Eligibilityv315
  5. 19 versions Re-verified since May 24, 2024, no change to tracked fieldsv296-v314
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the relationship of this disorder to kidney cancer. BHD is a rare inherited condition characterized by papules, or bumps-benign tumors involving hair follicles-on the head and neck. People with BHD are at increased risk of developing kidney cancer. Scientists have identified the chromosome (strand of genetic material in the cell nucleus) that contains the BHD gene and the region of the gene on the chromosome. This study will try to learn more about: * The characteristics and type of kidney tumors associated with BHD * The risk of kidney cancer in people with BHD * Whether more than one gene causes BHD * The genetic mutations (changes) responsible for BHD Individuals with known or suspected Birt Hogg-Dube syndrome, and their family members, may be eligible for this study. Candidates will be screened with a family history and review of medical records, including pathology reports for tumors, and films of computed tomography (CT) and magnetic resonance imaging (MRI) scans. Participants may undergo various tests and procedures, including the following: * Physical examination * Review of personal and family history with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor * Chest and other x-rays * Ultrasound (imaging study using sound waves) * MRI (imaging study using radiowaves and a magnetic field) * CT scans of the chest and abdomen (imaging studies using radiation) * Blood tests for blood chemistries and genetic testing * Skin evaluation, including a skin biopsy (surgical removal of a small skin tissue sample for microscopic evaluation) * Cheek swab or mouthwash to collect cells for genetic analysis * Lung function studies * Medical photography of skin lesions These tests will be done on an outpatient basis in either one day or over 3 to 4 days. When the studies are complete, participants will receive counseling about the findings and recommendations. Individuals with kidney lesions may be asked to return periodically, such as every 3 to 36 months, based on their individual condition, to document the rate of progression of the lesions.
Trial Details
NCT Number NCT00033137
Lead Sponsor National Cancer Institute (NCI)
Conditions Kidney Neoplasms, Kidney Cancer, Pneumothorax, FLCN Protein, Human
Enrollment 950 participants
Start Date
Updated on ClinicalTrials.gov