ctDNA Monitoring in Early Breast Cancer
Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
1 other identifier
observational
200
1 country
1
Brief Summary
This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 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
Study Start
First participant enrolled
November 29, 2019
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJuly 18, 2024
July 1, 2024
5.5 years
April 16, 2020
July 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive ctDNA detection at first post-operative timepoint
The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint
1 month post-surgery
Secondary Outcomes (3)
Positive ctDNA detection at post-operative timepoints
6/12/18/24/30 months
Association between ctDNA detection and time to recurrence
1 month post-surgery
Association between ctDNA detection and time to recurrence
6/12/18/24/30 months
Eligibility Criteria
Patients with stage I-III breast cancer who planed to receive curative-intent treatment.
You may qualify if:
- Patients aged 18 to 80 years old
- Histologically proven primary breast cancer with clinical stage I-III
- Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).
- Expected to achieve R0 resection.
- Estimated lifetime is more than 3 months.
- Signed Informed Consent Form
- Consent to provide research blood samples.
You may not qualify if:
- Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5.
- Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5.
- Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.
- Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geneplus-Beijing Co. Ltd.lead
- Army Medical University, Chinacollaborator
Study Sites (1)
Army Medical Center of PLA, China
Chongqing, Chongqing Municipality, 400042, China
Biospecimen
tumor and plasma specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 20, 2020
Study Start
November 29, 2019
Primary Completion
June 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
July 18, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share