Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00314119 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Natural History and Biology of Skin Neurofibromas in Neurofibromatosis Type 1

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 366 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Eligibility criteria expanded, about 25 words

    Publications: details revised at 1 of 1 entry

    Show what changed: Eligibility criteria
    -INCLUSION CRITERIA - GROUP A INDIVIDUALS: 1. Clinical diagnosis of NF1. In order to meet the diagnosis of [...] iduals must have 2 of the diagnostic criteria listed below: * Six or more cafe-au-lait macules (greater than or equal to 0 [...] r greater than or equal to 1.5 cm in postpubertal subjects) * Freckling in the axilla or groin * A tumor of the optic pathway * Two or more Lisch nodules * A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex) * A plexiform neurofibroma or two or more neurofibromas * A first-degree relative with NF1 by the above criteria [...] [...]

  3. Minor

    48 amendments

    48 re-verifications since 2025-02-01, no change to tracked fields

    v317-v364

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 explore the growth of dermal neurofibromas (skin tumors) in patients with neurofibromatosis type 1 (NF1). Investigators will try to learn: 1) how fast (or slow) these benign tumors grow in NF1, 2) how often new tumors appear and 3) what genes are involved in the growth of the tumors. Men and women between 20 and 50 years of age diagnosed with NF1 and their biological parents are eligible for this study. Patients with NF1 are evaluated at the NIH Clinical Center with the following tests and procedures: * Medical examination and drawing of family tree. * Photos of the back, abdomen and thigh in order to count the number of skin tumors. * Photos of the skin taken with a special camera (Primos camera) that takes very detailed pictures of a small area of skin. * Photos of the skin taken with a dermatoscope, which takes very detailed pictures of a small area of skin under high magnification. * Biopsy of at least one skin tumor and biopsy of a small piece of normal skin. * Blood sample collection for genetic testing of the gene NF1 and to establish a cell line. * Other medical tests (e.g., x-rays or MRI) if needed. Patients and their families will also have a genetic counseling session and an opportunity to ask questions about neurofibromatosis type 1. Patients return to the NIH after 3, 6, 12, 18 and 24 months for follow-up photographs and possibly blood samples. Biological parents of patients provide a blood sample for genetic testing. ...
Trial Details
NCT Number NCT00314119
Lead Sponsor National Cancer Institute (NCI)
Conditions Neurofibromatosis Type 1, Neurofibroma
Enrollment 17 participants
Start Date
Updated on ClinicalTrials.gov