Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
Prospective Study on the Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
1 other identifier
observational
60
1 country
1
Brief Summary
Breast cancer is the most common malignant tumor in women worldwide,and there exist a large part of patients need to receive neoadjuvant chemotherapy(NAC) before the curative surgery.Circulating tumor DNA(ctDNA) is the circulating free DNA in the blood that originates from cancers,and it can be detected by modern technologies in plasma.In this prospective study,investigators aim to observe the correlation between tumor response to neoadjuvant chemotherapy and ctDNA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2018
CompletedStudy Start
First participant enrolled
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2019
CompletedSeptember 27, 2018
September 1, 2018
1 year
August 30, 2018
September 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes
To assess the changes of ctDNA mutant copies during the process of our observation,and to find out the relationship between ctDNA and tumor response to neoadjuvant chemotherapy
From patients recruited into the research until the surgury complete ,assessed up to 26 weeks.
Secondary Outcomes (1)
disease free survival after surgery
Up to 5 years
Eligibility Criteria
Breast cancer patient receiving NAC in Shandong Cancer hospital
You may qualify if:
- Female patients undergoing neoadjuvant chemotherapy
- Age: 18-70 yrs
- Any menopausal status
- Any hormone receptor status
- Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):
- Locally advanced tumor
- Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.
You may not qualify if:
- Failed to retain blood sample before NAC
- Lost more than 2 blood samples during NAC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhiyong Yulead
Study Sites (1)
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Biospecimen
tissue samples from the surgery and blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhiyong Yu, PHD
Shandong Cancer Hospital and Institute
- PRINCIPAL INVESTIGATOR
Zhaoyun Liu, MD
Shandong Cancer Hospital and Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Breast Surgery Ⅰ
Study Record Dates
First Submitted
August 30, 2018
First Posted
September 27, 2018
Study Start
September 20, 2018
Primary Completion
September 20, 2019
Study Completion
September 20, 2019
Last Updated
September 27, 2018
Record last verified: 2018-09