Clinical trial · Observational
Monitoring of Breast Tissue Change Due to Hormone Replacement Therapy in Post-menopausal Women Using OBS
Short-term Evaluations of Breast Tissue Change in Post-menopausal Women Using Optical Breast Spectroscopy (OBS)
- 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)
Hormone Replacement Therapy (HRT) is a double edged sword: it can alleviate the effects of menopause for a significant proportion of the female population, however for a smaller proportion, it will induce a significant increase in their short-term and lifetime risk to develop breast cancer (BC). Fewer women are prescribed HRT compared to a decade ago due to concerns pertaining to BC by both physicians and patients. By developing a technology that could identify women at risk for the adverse effects of HRT, during the first few months of its use, physicians may offer HRT to a wider proportion of the female population during menopause. More importantly, as it relates to BC prevention, such a technology will identify women at risk and provide a useful decision making tool regarding their care during the menopausal years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- 1-Treatment Group 1
- description
- Women receiving HRT treatment of Premarin.
- label
- 2-Treatment Group 2
- description
- Women receiving combination HRT treatment of Premarin + Provera.
- label
- 3- Treatment Group 3
- description
- Women receiving combination HRT treatment of Premarin + Prometrium.
- label
- 4- Controls
- description
- Women not on HRT or healthy controls.
Primary outcomes (1)
- measure
- Changes in OBS parameters
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Cases Inclusion Criteria: * Post-menopausal * Attending the Endocrinology clinic at SMH * Will start HRT treatment Exclusion Criteria: * Current or Past HRT treatment * Prior breast cancer * Benign breast disease * Bilateral breast biopsy * Fine needle aspiration (FNA) within a year * Cosmetic alteration (reduction/augmentation) * Gynecological surgery * Past or current chemo- therapeutic or prevention treatment Controls Inclusion Criteria: * Not on HRT treatment Exclusion Criteria: * Current or Past HRT treatment * Prior breast cancer * Benign breast disease * Bilateral breast biopsy * Fine needle aspiration (FNA) within a year * Cosmetic alteration (reduction/augmentation) * Gynecological surgery * Past or current chemo- therapeutic or prevention treatment
References
Publications (4)
- BACKGROUNDBlyschak K, Simick M, Jong R, Lilge L. Classification of breast tissue density by optical transillumination spectroscopy: optical and physiological effects governing predictive value. Med Phys. 2004 Jun;31(6):1398-414. doi: 10.1118/1.1738191. PMID 15259643
- BACKGROUNDSimick MK, Jong R, Wilson B, Lilge L. Non-ionizing near-infrared radiation transillumination spectroscopy for breast tissue density and assessment of breast cancer risk. J Biomed Opt. 2004 Jul-Aug;9(4):794-803. doi: 10.1117/1.1758269. PMID 15250768
- BACKGROUNDBlackmore KM, Knight JA, Jong R, Lilge L. Assessing breast tissue density by transillumination breast spectroscopy (TIBS): an intermediate indicator of cancer risk. Br J Radiol. 2007 Jul;80(955):545-56. doi: 10.1259/bjr/26858614. Epub 2007 May 30. PMID 17537757
- BACKGROUNDSimick MK, Lilge L. Optical transillumination spectroscopy to quantify parenchymal tissue density: an indicator for breast cancer risk. Br J Radiol. 2005 Nov;78(935):1009-17. doi: 10.1259/bjr/14696165. PMID 16249602