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Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer

1. desember 2014 oppdatert av: Catherine Van Poznak, University of Michigan

This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

The goal of this research is to build an index of risk for estimating an individual's risk of developing osteonecrosis of the jaw (ONJ). The bisphosphonates are an important supportive therapy in the care of patients with metastatic bone disease; they are able to prevent catastrophic events such as fracture and spinal cord compression. However, ONJ has been associated with the use of the bisphosphonates and ONJ carries significant morbidity. Presently, there are insufficient data to calculate the ONJ risk benefit ratio of bisphosphonate use. An ONJ risk assessment tool would improve both the oncologist's and the dental health professional the ability to anticipate and potentially mitigate oral toxicities from bisphosphonate therapy.

This protocol consists of a case (ONJ) control (no ONJ) study to identify factors associated with the risk of ONJ and to build an index predictive of an individual's risk of developing ONJ. The index of ONJ risk will be comprised of clinical, epidemiologic and genetic factors

Studietype

Observasjonsmessig

Registrering (Faktiske)

271

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48109
    - University of Michigan

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Academic medical center(s)

Beskrivelse

Inclusion Criteria:

The study candidate must have sufficient Formalin Fixed Paraffin Embedded (FFPE)Specimens (lymph node or tumor) for DNA extraction available for study SNP assessment
Patients over the age of 21 with a histologically confirmed diagnosis of cancer who have received nitrogen containing bisphosphonate therapy for metastatic bone disease.
FFPE tissues are to have been removed for clinical indication and sufficience study volume of specimen must be available in an established tissue repository.
- Study FFPE tissues include:
- formalin fixed paraffin embedded leukocytes from lymph nodes with or without involvement by tumor AND/OR
- formalin fixed paraffin embedded tumor tissue (tumor block without invasive cancer is acceptable if the specimen is believed to be sufficiently cellular (breast tissue or noninvasive cancer) to yield adequate DNA)
Medical records available for data abstraction

Exclusion Criteria:

Insufficient specimen available to perform the assays proposed for specimen DNA analysis
No accessable medical records

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
ONJ Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ
No ONJ Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate. Tidsramme: 2009-2014	analysis is ongoing	2009-2014
To identify single nucleotide polymorphisms (SNPs) in genes affected by osteoclast inhibiting therapy that are associated with an increased risk of developing ONJ in patients with metastatic bone disease treated with nitrogen containing bisphosphonates. Tidsramme: 2009-2014	analysis is ongoing	2009-2014
To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors Tidsramme: 2009-2014	analysis is ongoing	2009-2014

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Michigan

Samarbeidspartnere

M.D. Anderson Cancer Center

Memorial Sloan Kettering Cancer Center

National Institute of Dental and Craniofacial Research (NIDCR)

Indiana University

Etterforskere

Hovedetterforsker: Catherine Van Poznak, MD, University of Michigan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2010

Primær fullføring (Faktiske)

1. november 2014

Studiet fullført (Faktiske)

1. november 2014

Datoer for studieregistrering

Først innsendt

28. mars 2011

Først innsendt som oppfylte QC-kriteriene