Clinical trial · Observational
Prospective Breast Cancer Biospecimen Collection
NCT04074720CI-TRIAL-00098326recruitingClinicalTrials.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)
Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death
Conditions
Conditions (3)
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 |
| Carcinoma in Situ of the Breast | — | UNRESOLVED | — |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Other | — | UNRESOLVED |
| Rectal Swab | Other | — | UNRESOLVED |
| Tissue Sample collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1: Newly Diagnosed Breast Cancer Patients
- description
- Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death.
- interventionNames
- Procedure: Tissue Sample collection
- Other: Blood Sample Collection
- Other: Rectal Swab
- label
- Group 2: Patients with Brain Metastases from Primary Breast Cancer
- description
- The brain metastasis specimen experiments will use tissue from 36 patients (12 per subtype: estrogen positive, Her-neu-2 positive, and triple negative). Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death.
- interventionNames
- Procedure: Tissue Sample collection
- Other: Blood Sample Collection
- Other: Rectal Swab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults \>18 years old at time of consent * Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf. * Patients with carcinoma in situ or invasive breast cancer * Patient must be undergoing one of the following: * definitive surgical tumor resection for breast cancer OR * placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR * neurosurgical resection of a brain metastasis from primary breast cancer. Exclusion Criteria: * \<18 years old * Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent. * Active drug/alcohol dependence or abuse history
References
Publications (0)
Data not yet available
No reference posted for this study.