Image

Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Renal and Other Urologic Malignant Disorders

Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Renal and Other Urologic Malignant Disorders

Recruiting
2 years and older
All
Phase N/A

Powered by AI

Overview

We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled. Affected individuals or individuals suspected of having a germline urologic malignant disorder will undergo periodic clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype/phenotype correlation. Genetic linkage studies may be performed in situations in which the genetic basis of the disorder has not been elucidated.

...

Description

Background
  • Disorders under investigation are: Autosomal dominant inherited urologic malignant disorders including: von Hippel-Lindau (VHL), hereditary papillary renal cancer (HPRC), Birt Hogg Dube (BHD) and hereditary leiomyomatosis and renal cell acarcinoma (HLRCC) as well as familial renal cancer.
  • Studies have led to the identification and characterization of the VHL, HPRC, FLCN and HLRCC genes.
  • The genetic etiology of the most common type of inherited kidney cancer, familial renal cancer (FRC), remains to be determined.
    Objectives
  • To characterize the natural and clinical histories of inherited urologic malignant disorders.
  • To determine the genetic etiology of hereditary urologic malignant disorders in which the gene variation is unknown, by linkage analysis, positional cloning and evaluation of candidate genes.
  • To correlate specific mutations and their associated protein domains with disease phenotypic expression based on parameters including presenting age, clinical manifestations, histopathology and rate of recurrence.
  • To identify and describe as yet unknown or uncharacterized inherited urologic malignant disorders.
    Eligibility
  • Individuals and biologic family members with a suspected or an established diagnosis of an inherited urologic malignancy in which the disease gene is known, including von Hippel-Lindau (VHL) and hereditary papillary renal carcinoma (HPRC).
  • Individuals and biologic family members with a suspected or an established diagnosis of an inherited urologic malignancy in which the disease gene is not yet known, specifically hereditary forms of Type II papillary renal cancer, clear cell renal carcinoma, renal oncocytoma, chromophobe renal carcinoma or Birt Hogg Dube.
  • Individuals and biologic family members who have urologic malignant diseases of suspected, but not proven genetic etiology, including families with more than one individual affected by the same or related cancers.
    Design
  • These rare families will be recruited to genetically confirm diagnosis, determine size and location of renal tumors, size at presentation, growth rate and metastatic potential of renal tumors.
  • Genetic testing will be offered to gain appreciation of the effect of mutations on the relative activity of various germline and somatic mutations.
  • We will determine if there is a relationship between mutation and disease manifestations and phenotype.

Eligibility

  • INCLUSION CRITERIA:
        Participants must be greater than or equal to 2 years of age. All patients and guardians
        (for children younger than 18 years of age) must sign an informed consent document
        indicating their understanding of the investigational nature and the risks of this study
        before any protocol related studies are performed. Patients under the age of 18 but who are
        age 13 or older will be asked to sign an assent document prior to participation.
        Criteria for Acceptance into this Study (i.e., Disease Categories):
        Disease Category I
        Individuals and biologic family members with a suspected or an established diagnosis of an
        inherited urologic malignancy in which the disease gene is known, including von
        Hippel-Lindau (VHL) and hereditary papillary renal carcinoma (HPRC).
        Disease Category II
        Individuals and biologic family members with a suspected or an established diagnosis of an
        inherited urologic malignancy in which the disease gene is not yet known, specifically
        hereditary forms of Type II papillary renal cancer, clear cell renal carcinoma, renal
        oncocytoma, chromophobe renal carcinoma or Birt Hogg Dube.
        Disease Category III
        Individuals and biologic family members who have urologic malignant diseases of suspected,
        but not proven genetic etiology, including families with more than one individual affected
        by the same or related cancers. A total of 5000 individuals will be enrolled during the
        study (i.e., that includes individuals registered since the beginning of the protocols in
        1989 (89C0086) and 1999 (99C0101)).
        Enrollment per Subject Category (to include both affected and unaffected biologic
        relatives)
        Subject Category A:
        Category A will include patients, and biologic relatives, who may or may not be affected
        who will be evaluated in the Warren G. Magnuson Clinical Center. Patients in this category
        will be eligible if they or their biologic family members manifest one or more of the
        following features in a pattern suggestive of a heritable urologic malignant disorder:
          -  One or more histologically proven or suspected renal carcinomas and/or cysts
          -  Cerebellar, spinal, medullary or cerebral hemangioblastomas
          -  Retinal angioma
          -  Pancreatic neuro-endocrine carcinoma, microcystadenoma and/or cysts
          -  Pheochromocytoma
          -  Papillary cystadenoma of the epididymis or broad ligament
          -  Endolymphatic sac tumor
          -  Cutaneous fibrofolliculomas or multiple skin-colored papules
          -  History of spontaneous pneumothorax
          -  Lung cysts
          -  Thyroid carcinoma
          -  Intestinal polyposis + / - colon cancer
          -  Cutaneous or Uterine leiomyoma or uterine leiomyosarcoma, sarcoma
        Subject Category B:
        Category B will include patients and the biologic relatives of patients with inherited
        urologic malignancies with the above listed clinical findings who live at a distance and
        who will not be evaluated at the Clinical Center. In some cases, local diagnostic testing
        may be necessary for these individuals in addition to collection of a blood sample for
        molecular analysis.
        Subject Category C:
        Category C will include biologic relatives who enroll in this study primarily for genetic
        linkage studies. These individuals will contribute a blood sample for DNA analysis only. No
        imaging diagnostic testing will be performed on individuals from this category.
        EXCLUSION CRITERIA:
        None

Study details
    Kidney Cancer
    Urologic Malignant Disorders
    Renal Cell Carcinoma
    Familial Renal Cancer (FRC)
    Clear Cell Renal Cancer

NCT00001238

National Cancer Institute (NCI)

26 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.