Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorHunan Cancer Hospital
About this trial
The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Early stage breast cancer patients
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
CTC detection
Diagnostic testCTCs separation and enrichment technology. Combined with the prognosis of patients with recurrence and survival time, we explored the evaluation of CTC number, cell phenotype distribution, PDL1 and FOXC2 expression on the prognosis of early stage breast cancer patients. The research results are expected to provide a new effective index and theoretical basis for evaluating the treatment efficacy of breast cancer patients.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Breast cancer patients1 intervention
Trial outcomes
Primary outcomes
1
iDFS
The survival time from the date of tumor resection to the date of the relapse of the invasive disease.
Time frame
From date of enrollment through study completion, up to 10 years.Secondary outcomes
1
overall survival
The survival time from the date of recruitment to the date of death.
Time frame
From date of enrollment through study completion, up to 10 years.2
Pathological complete response rate
pCR is defined as no infiltrating tumor cells in pathological examination in the primary breast and axillary lymph nodes.
Time frame
From date of enrollment up to 24 weeksSponsors and contacts
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Source ClinicalTrials.gov