Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00050752 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 367 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Re-verified, no change to tracked fields
  3. Minor Eligibility criteria expanded, about 10 words Study description expanded, about 17 words Show all 2 changesShow less
    • Study description expanded, about 17 words
  4. Minor 26 versions Re-verified since Sep 12, 2025, no change to tracked fieldsv339-v364
  5. Minor Eligibility criteria shortened, about 24 wordsv338 Show moreShow less
Show 20 earlier versionsHide 20 earlier versions
  1. Minor Study Status, Study Description, Arms and Interventions, Eligibilityv337
  2. Minor 12 versions Re-verified since Apr 22, 2025, no change to tracked fieldsv325-v336
  3. Minor Enrollment target: 950 to 1130v324
  4. Minor 6 versions Re-verified since Jan 31, 2025, no change to tracked fieldsv318-v323
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 what causes hereditary leiomyomatosis renal (kidney) cell cancer, or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are benign (non-cancerous) tumors arising from smooth muscle. HLRCC can cause various health problems. Some people develop red bumps on their skin that can be painful at times. Some women with HLRCC can develop leiomyomas of the uterus. In some families, people with HLRCC develop kidney tumors. This study will try to determine: * What gene changes (mutations) cause HLRCC * What kind of kidney tumors develop in HLRCC and how they grow * What the chance is that a person with HLRCC will develop a kidney tumor People with known or suspected HLRCC (and their family members of any age) may be eligible for this study. This includes people in families in which one or more members has skin leiomyoma and kidney cancer; skin leiomyoma and uterine leiomyoma; multiple skin leiomyomas; kidney cancer and uterine leiomyomas, or kidney cancer consistent with HLRCC, including, but not limited to, collecting duct or papillary, type II. Candidates will be screened with a physical examination, family history, and, for affected family members, a review of medical records, including pathology slides and computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will undergo tests and procedures that may include the following: * Review of medical records, x-rays, and tissue slides * Physical examination and family history * Skin examination * Gynecological examination for women * Interviews with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor * Blood tests for: 1. Genetic research to identify the gene responsible for HLRCC 2. Evaluation of liver, kidney, heart, pancreas, and thyroid function 3. Complete blood count and clotting profile 4. Pregnancy test for pre-menopausal women 5. PSA test for prostate cancer in men over age 40 * CT or MRI scans (for participants 15 years of age and older only) * Skin biopsy (surgical removal of a small sample of skin tissue) * Cheek swab or mouth rinse to collect cells for genetic analysis * Medical photographs of lesions * Questionnaire When the tests are completed, participants will discuss the results with a doctor and possibly a genetic nurse or genetic counselor. The genetic findings will not be revealed to participants because their meaning and implications may not yet be understood. Participants may be asked to return to NIH from every 3 months to every 3 years, depending on their condition, for follow-up examinations and tests.
Trial Details
NCT Number NCT00050752
Lead Sponsor National Cancer Institute (NCI)
Conditions Renal Tumor Histology, Cutaneous Leiomyoma, Kidney Cancer
Enrollment 1,130 participants
Start Date
Updated on ClinicalTrials.gov