Evaluating tumor cell characteristics in breast cancer patients
Surveillance of Circulating Tumor Cell Phenotype in Early Stage Breast Cancer Patients With Neoadjuvant Chemotherapy or Adjuvant Chemotherapy
This study is testing if tracking certain tumor cells in breast cancer patients can help predict how well they respond to treatment after chemotherapy and surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Hunan Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05326295 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy of circulating tumor cell (CTC) surveillance in predicting treatment response in breast cancer patients who have undergone neoadjuvant chemotherapy and surgery. It will evaluate how CTC phenotype correlates with invasive-disease free survival, overall survival, and metastasis. Additionally, the study will analyze the expression of specific markers, PDL1 and FOXC3, on CTCs to further understand their prognostic significance.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of malignant breast tumors who have completed neoadjuvant chemotherapy and surgery.
Not a fit: Patients with other malignancies, uncontrolled infections, or significant physical or mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting patient outcomes and tailoring treatment strategies in breast cancer.
How similar studies have performed: Other studies have shown promise in using CTC surveillance for prognosis in various cancers, suggesting potential success for this approach in breast cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * The age is more than 18 years old; * Pathology confirmed malignant breast tumor; * No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection; * Life expectancy is greater than 6 month; * The main organ function is normal; * The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance. Exclusion Criteria * Patients who had suffered from other malignant tumors; * With uncontrolled bacterial, viral or fungal infections; * With physical or mental disorders * Without or limited civil capacity; * Infected with human immunodeficiency virus (HIV)； * Circumstances in which the investigator considers it inappropriate to participate in this study.
Where this trial is running
Changsha, Hunan
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Quchang Ouyang
- Email: oyqc1969@126.com
- Phone: +8673189762161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.