Clinical trial · Observational
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
NCT01325142CI-TRIAL-00016169completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bisphosphonate-Associated Osteonecrosis of the Jaw | — | UNRESOLVED | — |
| Bone Diseases | — | UNRESOLVED | — |
| Metastases | — | UNRESOLVED | — |
| Osteonecrosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- ONJ
- description
- Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ
- label
- No ONJ
- description
- Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ
Primary outcomes (3)
- measure
- To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.
- timeFrame
- 2009-2014
- description
- analysis is ongoing
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.