Last reviewed · How we verify
NCT04245150
Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity
trial testing Stool sample in DCIS in 23 participants. Completed in 30 July 2024.
30 July 2024
Quick facts
| Lead sponsor | Case Comprehensive Cancer Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 23 |
| Start date | 21 March 2019 |
| Primary completion | 30 July 2024 |
| Estimated completion | 30 July 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Stool sample — full drug profile →
- Skin Swab Sample
Conditions studied
- DCIS — all drugs for DCIS →
- Invasive Breast Cancer — all drugs for Invasive Breast Cancer →
Sponsor
Case Comprehensive Cancer Center — full company profile →
Who can join
18 and older, female only, with DCIS or Invasive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of Gut Microbiota in Breast Cancer and Drug Resistance.
Viswanathan S, Parida S, Lingipilli BT, Krishnan R, et al · · 2023 · cited 38× · PMID 36986390 · DOI 10.3390/pathogens12030468 -
Emerging Role of Gut Microbiota in Breast Cancer Development and Its Implications in Treatment.
Mir R, Albarqi SA, Albalawi W, Alatwi HE, et al · · 2024 · cited 14× · PMID 39728464 · DOI 10.3390/metabo14120683 -
Gut microbiota interact with breast cancer therapeutics to modulate efficacy.
Arnone AA, Ansley K, Heeke AL, Howard-McNatt M, et al · · 2025 · cited 9× · PMID 39820166 · DOI 10.1038/s44321-024-00185-0 -
The Role of the Microbiome in Cancer Therapies: Current Evidence and Future Directions.
Chalif J, Goldstein N, Mehra Y, Spakowicz D, et al · · 2025 · cited 5× · PMID 39856008 · DOI 10.1016/j.hoc.2024.12.005 -
Microbiome-targeted nanoplatforms and engineering approaches in breast cancer therapy.
Sabeel Z, Yang Z. · · 2025 · cited 2× · PMID 41168838 · DOI 10.1186/s12943-025-02456-x -
Microorganisms and Breast Cancer: An In-Depth Analysis of Clinical Studies.
Naderi N, Mosahebi A, Williams NR. · · 2023 · cited 2× · PMID 38276152 · DOI 10.3390/pathogens13010006
Verify or expand the search:
- PubMed search for NCT04245150
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Stool sample
Trials testing the same drug.
- NCT05842343 — Food Intake and IgA Microbiota in Anorexia Nervosa · NA · terminated
- NCT05747651 — 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 · active not recruiting
- NCT05794620 — Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings · completed
- NCT05176795 — Host-microbiota-environment Interactions · terminated
- NCT06302660 — Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors · active not recruiting
Other recruiting trials for DCIS
Currently open trials in the same condition.
- NCT05912569 — Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS · NA · recruiting
- NCT04797299 — Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS) · recruiting
- NCT04722692 — Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ · Phase 3 · recruiting
- NCT04084730 — Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer · Phase 2 · recruiting
- NCT04049214 — Perioperative Mindfulness Proposal · NA · recruiting
Other Case Comprehensive Cancer Center trials
Trials by the same sponsor.
- NCT06811454 — Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET) · NA · not yet recruiting
- NCT07167056 — Artificial Intelligence-Powered Support For Quality Of Life Improvement In Participants With Cancer · NA · recruiting
- NCT07084779 — Investigation of Impact of AI on Prostate Cancer Workflow · NA · recruiting
- NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood · Phase 2 · recruiting
- NCT07044362 — Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04245150 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Case Comprehensive Cancer Center
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04245150.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing