Clinical trial · Observational
Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity
NCT04245150CI-TRIAL-00080591completedClinicalTrials.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)
Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Skin Swab Sample | Other | — | UNRESOLVED |
| Stool sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ductal Carcinoma In Situ (DCIS) or invasive breast cancer
- description
- Participants with DCIS or invasive breast cancer
- interventionNames
- Other: Stool sample
- Other: Skin Swab Sample
Primary outcomes (3)
- measure
- Microbiome profile as assessed by stool sample
- timeFrame
- At baseline
- description
- Microbiome profile as assessed by stool sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample
- measure
- Microbiome profile as assessed by breast skin sample
- timeFrame
- At baseline
- description
- Microbiome profile as assessed by breast skin sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients with DCIS or invasive breast cancer * Undergoing breast conserving surgery and adjuvant radiation * Subjects must be willing and able to provide breast skin samples Exclusion Criteria: * Active clinical breast infection (on antiobiotic for skin/breast infection or clinical diagnosis) * Refuse or are unable to sign informed consent form * Past history of breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.