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Trial Title:
Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy
NCT ID:
NCT05649475
Condition:
Stage I-III Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
In the prospective, open, observational study, we aim to evaluate whether circulating
tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III
breast cancer.
Criteria for eligibility:
Study pop:
Patients with stage I-III breast cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patient is ≥ 18 years-old at the time of consent to participate this trial
- Patients with stage I-III invasive breast cancer
- No prior anti-cancer treatment
- Felt to be a possible candidate for neoadjuvant therapy by their physician
Exclusion Criteria:
- Known to have other aggressive malignant tumor in the past 5 years.
- Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory
disease, pregnancy and other conditions may affect the levels of ctDNA and/or
peripheral inflammatory indicators.
- There are other concomitant diseases that seriously threaten the patient's safety or
affect the patient's completion of the study, such as serious infection, liver
disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled
diabetes or dyslipidemia.
- The investigator determines that subjects are not appropriate to participate in the
study due to other factors.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yiding Chen
Investigator:
Last name:
Yiding Chen
Email:
Principal Investigator
Start date:
August 31, 2021
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
GeneCast Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05649475
