The Association Between Plasma Metabolites and the Risk, Efficacy and Prognosis in Early Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorShengjing Hospital
About this trial
This study investigates plasma metabolites to clarify the relationship between these metabolites and breast cancer, aiming to identify valuable biomarkers. Furthermore, by incorporating clinical information-such as cancer stage, type, treatment outcomes, and prognosis-into prospective studies, the research seeks to further examine the correlation between plasma metabolites, treatment efficacy, and prognosis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Cohort 1 Control Group: women without breast cancer or other malignancies. Case Group: patients with histologically confirmed carcinoma in situ or invasive breast cancer; no prior treatment; no distant metastasis; and not associated with other malignant tumor diseases.
Cohort 2 Pathologically diagnosed as breast cancer; Treatment niave patients; To receive standard neoadjuvant therapy; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) .
Cohort 3 Patients who have been discharged after breast cancer treatment.
Disqualifiers
Histologically undiagnosed breast cancer. Breast cancer with distant metastases. Combined with other malignant tumors. Participants must not have participated in other clinical trials within the past month, unless those trials are observational or non-interventional in nature.
Trial population
The participants included individuals without tumors, patients diagnosed with breast cancer , and patients who have been discharged after breast cancer treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionThere is no intervention in this study. We will obtain blood from the recruited patients and assess the metabolites therein. This is an observational work.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: cohort 11 intervention
Group B: cohort 21 intervention
Group C: Cohort 31 intervention
Trial outcomes
Primary outcomes
1
Cohort 1 : Different Plasma Metabolites
To measure the plasma metabolites of non-tumor individuals and breast cancer patients, and to analyze the differential metabolites between the two populations.
Time frame
2 years2
Cohort 2: Different Plasma Metabolites
pCR refers to the complete pathological remission of tumor lesions following neoadjuvant chemotherapy. To measure the plasma metabolites of breast cancer patients both before and after neoadjuvant chemotherapy, and to analyze the differential metabolites between patients who achieve pCR and those who do not.
Time frame
2 years3
Cohort 3: Different Plasma Metabolites
The metabolites in the blood of discharged breast cancer patients were measured regularly, and the differences in metabolites between patients with disease recurrence or metastasis and those without recurrence or metastasis within a 5-year period were analyzed.
Time frame
7 yearsSponsors and contacts
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Source ClinicalTrials.gov