NCT01325142

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

March 28, 2011

Last Update Submit

December 1, 2014

Conditions

Bone DiseasesMetastasesOsteonecrosisBisphosphonate-Associated Osteonecrosis of the Jaw

Keywords

Osteonecrosis of the Jaw (ONJ)

Outcome Measures

Primary Outcomes (3)

  • To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.

    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.

    analysis is ongoing

    2009-2014

  • To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors

    analysis is ongoing

    2009-2014

Study Arms (2)

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Academic medical center(s)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

paraffin embedded tissue block and/or WBC

MeSH Terms

Conditions

Bone DiseasesNeoplasm MetastasisOsteonecrosisBisphosphonate-Associated Osteonecrosis of the Jaw

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisJaw DiseasesStomatognathic Diseases

Study Officials

  • Catherine Van Poznak, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priniciple Investigator

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

August 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(1)