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Cancer Risk in Individuals Who Have a Xeroderma Pigmentosum Gene Alteration Compared With Those Who Don't
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: November 12, 2002   Last Updated: June 16, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049621
  Purpose

RATIONALE: Screening individuals who have a xeroderma pigmentosum gene alteration may help doctors identify persons at risk of developing cancer and identify other cancer genes.

PURPOSE: This clinical trial is comparing cancer risk in individuals who have a xeroderma pigmentosum gene alteration to those who don't.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Other: physiologic testing
Procedure: mutation carrier screening
Procedure: study of high risk factors

Study Type: Interventional
Study Design: Screening, Open Label
Official Title: Cancer Risk In Xeroderma Pigmentosum Heterozygotes

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 800
Study Start Date: August 2002
Detailed Description:

OBJECTIVES:

  • Compare risk of developing any type of cancer in participants who are heterozygous carriers of xeroderma pigmentosum (XP) disease gene mutations vs non-carrier blood relatives or spouses.
  • Compare risk of developing skin cancers or cancers of the nervous system in these participants.
  • Compare cancer risk in different groups among heterozygous carriers of XP disease gene mutations.
  • Compare cancer risk in carriers of different XP disease gene mutations with heterozygous carriers of these gene mutations.

OUTLINE: Participants undergo general cancer screening comprising a medical history and physical examination, including a skin and neurologic examination. Laboratory samples are collected for review.

Participants are followed annually by telephone or mail to determine clinical status.

PROJECTED ACCRUAL: Approximately 800 participants (400 heterozygous carriers and 400 non-carrier blood relatives or spouses) will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • One of the following:

    • Blood relative of a patient diagnosed with xeroderma pigmentosum (XP)
    • Spouse of a blood relative of a patient with XP
    • Spouse of a patient with XP
    • Family member of patient with clinical documentation of features of XP and laboratory determination of DNA repair defect
  • Evaluation of proband at the Warren Grant Magnuson Clinical Center or newly diagnosed on other approved protocols (e.g., NCI-99-C-0099)

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Able and willing to provide family history information
  • Able and willing to provide tissue (skin, blood, buccal cells, or hair) for laboratory studies

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049621

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892
Contact: Patient Recruitment     888-NCI-1937        
Sponsors and Collaborators
Investigators
Study Chair: Kenneth H. Kraemer, MD NCI - Basic Research Laboratory
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000258132, NCI-02-C-0313
Study First Received: November 12, 2002
Last Updated: June 16, 2009
ClinicalTrials.gov Identifier: NCT00049621     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Xeroderma Pigmentosum
Metabolic Diseases
Keratosis
Skin Diseases
Precancerous Conditions
Photosensitivity Disorders
Pigmentation Disorders
DNA Repair-Deficiency Disorders
Skin Abnormalities
Ichthyosis
Neoplasms
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Congenital Abnormalities
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 09, 2009