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Clinical Trial VICCSUPP1224

Title

Osteonecrosis of the Jaw Case (ONJ) Registry

Principal Investigator(s)

Barbara Murphy

Details

  • Protocol No. VICCSUPP1224
  • Open Date: 11/19/2012
  • Staging: N/A
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective of the ONJ case registry is - Estimate the rate and describe the time course of resolution of ONJ: - Resolution: complete coverage of the exposed bone by mucosa in the absence of clinical symptoms - Improvement: a decrease in the stage or severity of the lesion - Progression: an increase in the stage or severity of the lesion - Stable: not resolved, improved, or progressed
  • Disease Sites: Breast; Head/Neck; Prostate
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01666106
  • Secondary Protocol No: 20101102

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Adult (≥18 years of age) with diagnosis of cancer
• Newly diagnosed, positively-adjudicated ONJ
• ECOG <=2 and expected survival ≥3 months
• Willing to provide access to previous and future medical and dental information
• Subject or subject's legally acceptable representative has provided written informed consent
Exclusion Criteria:
• History of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer
• Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge.
• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.