Clinical trial · Observational
Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (CTC)
Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer
- 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)
The purpose of the study is to determine whether the type of anesthesia during breast cancer surgery has any impact on the way a patient's immune system functions for a brief period after surgery. If the investigators find that one type of anesthesia versus the other is more beneficial to a patient's immune system, then the investigators may use this information to design a larger study to exam the effect of anesthesia better.
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 (0)
[]Primary outcomes (1)
- measure
- Circulating Tumor Cells
- timeFrame
- 5 days
- description
- blood will be drawn preoperative( at least 24 hours before surgery), immediate prior to surgery, immediately postoperative, 12-24 hours postoperative, and at postoperative appointment
Secondary outcomes (5)
- measure
- Levels of cytokines
- timeFrame
- 5 days
- measure
- breast cancer antibodies
- timeFrame
- 5 days
- measure
- Dendritic Cells
- timeFrame
- 5 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subjects should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy * Written informed consent must be obtained from each subject prior to entering the study * Subjects with primary non-metastatic AJCC stages I, II or III, scheduled to undergo either unilateral mastectomy with or without Sentinel lymph node biopsy or axillary dissection, or unilateral lumpectomy with Sentinel lymph node biopsy or axillary lymph node dissection * Able to stay overnight in the hospital post surgery Exclusion Criteria: * Any subject younger than 18 years or older than 85 years of age * History of previous breast surgery (aside from biopsy), planned breast conserving operation (isolated lumpectomy) or reconstruction (rectus or latissimus flap) * American Society of Anesthesia (ASA) classification of 4 or greater, or any contraindication to having regional anesthesia * Any subjects who receives an intraoperative or postoperative blood transfusion during the period of venous blood sampling * Subjects who are pregnant. Exclusion of the possibility of pregnancy by testing (urine HCG) or by history (tubal ligation, hysterectomy, or menopause) is required prior to inclusion in the study * Subjects with active infectious process at the site of proposed paravertebral injection * Subjects with significant allergy to local anesthetics * Subjects who convert from RA to GA during surgery
References
Publications (0)
Data not yet available