Trials / Terminated
TerminatedNCT00899288
Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98
Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- ETOP IBCSG Partners Foundation · Network
- Sex
- Female
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer may help in evaluating bone health in postmenopausal women undergoing hormone therapy for breast cancer. PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial IBCSG-1-98.
Detailed description
OBJECTIVES: Primary * Compare the effects of tamoxifen vs letrozole on the chemical properties of fingernails by Raman spectroscopy in postmenopausal women with breast cancer undergoing adjuvant hormonal therapy on protocol IBCSG-1-98. * Determine the efficacy of nail structure for evaluating bone fragility. Secondary * Compare fingernail assessments in patients who have had a bone fracture vs those who have not. * Determine the natural variation in chemical (Raman spectroscopy) properties of 2 fingernails sourced at 1 appointment from the same donor. * Evaluate the effect of further drug treatment (after 6 months) on the chemical properties of fingernails. OUTLINE: This is a single-blind, multicenter, pilot study. Patients are stratified according to treatment on protocol IBCSG-1-98 (tamoxifen vs letrozole) and bone fracture (yes vs no). Fingernail clippings are collected at baseline and 6 months later. Fingernail clippings are examined by Raman spectroscopy. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | spectroscopy | Nails will be chemically characterized using Raman spectroscopy. |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2007-07-01
- Completion
- 2007-07-01
- First posted
- 2009-05-12
- Last updated
- 2012-07-27
Source: ClinicalTrials.gov record NCT00899288. Inclusion in this directory is not an endorsement.