Breast CancerNCT04353557
ctDNA Monitoring in Early Breast Cancer
An observational study of Breast Cancer, run by Geneplus-Beijing Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage I-III breast cancer who planed to receive curative-intent treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Army Medical Center of PLA, China
Chongqing, Chongqing Municipality, 400042
Yan Xu, M.D., (+86)159 2310 0038, xy931@163.com
About this study
Official title: Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
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.
- Conditions
- Breast Cancer
- Keywords
- ctDNA
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month post-surgery
Secondary outcomes (3)
Positive ctDNA detection at post-operative timepoints
The proportion of patients with ctDNA positivity as assessed by the blood sample taken at other post-operative timepoints
Measured: 6/12/18/24/30 months
Association between ctDNA detection and time to recurrence
Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA comparison.
Measured: 1 month post-surgery
Association between ctDNA detection and time to recurrence
Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA
Measured: 6/12/18/24/30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start29 Nov 2019
- Primary completionJun 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Army Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353557
- Sponsor's protocol ID
- Geneplus2020BC01
- Status last verified
- Jul 2024
- First submitted
- 16 Apr 2020
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04353557
- Acronym / sponsor ID
- Geneplus2020BC01
- Conditions
- Breast Cancer
- Keywords
- ctDNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Geneplus-Beijing Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Army Medical University, China
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I-III breast cancer who planed to receive curative-intent treatment.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive ctDNA detection at first post-operative timepoint
Time frame: 1 month post-surgery
The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint
3 secondary outcomes
Positive ctDNA detection at post-operative timepoints
Time frame: 6/12/18/24/30 months
Association between ctDNA detection and time to recurrence
Time frame: 1 month post-surgery
Association between ctDNA detection and time to recurrence
Time frame: 6/12/18/24/30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Geneplus-Beijing Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Xu, M.D. ((+86)159 2310 0038, xy931@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive ctDNA detection at first post-operative timepoint (time frame: 1 month post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.