Invasive Breast CancerCTREPNCT03247478
Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure
An observational study of Invasive Breast Cancer, run by Peking University at 1 site in China.
Trial summary
This is a prospective, single-center, non-randomized, non-controlled observational study. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Invasive Breast Cancer
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2017to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Invasive breast cancer with axillary lymph node metastasis: stage N1-2.
Who may be able to join
- Invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB).
- Underwent computed tomography (CT) reconstruction for assessment of axillary lymph node status before and after neoadjuvant chemotherapy (NAC).
- Attend the study voluntarily, sign the informed consent.
Who cannot join
- Contradiction for adjuvant chemotherapy.
- Contradiction for proceeding surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure: a Prospective Observational Study Evaluating Response in Axillary Lymph Nodes of Breast Cancer After Neoadjuvant Chemotherapy
This is a prospective, single-center, non-randomized, non-controlled observational study.
Read the detailed description
The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to axillary lymph node. The aim of this study is to determine performance of computed tomography (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients.
- Conditions
- Invasive Breast Cancer
- Keywords
- Computed tomography (CT) reconstruction, axillary lymph node status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| invasive breast cancer | Patients with invasive breast cancer who underwent computed tomography (CT) reconstruction of axillary lymph node for assessment of lymph node response after NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy.
Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy will be assessed.
Measured: within 6 weeks after obtaining the post-surgery pathological results
Secondary outcomes (1)
Rreceiver operating characteristic (ROC) curve analysis
The diagnostic performance of computed tomography (CT) reconstruction for the evaluation of ALN after NAC was evaluated with receiver operating characteristic (ROC) curve analysis. The diagnostic accuracy was estimated by calculating the area under the ROC curve.
Measured: within 6 weeks after obtaining the post-surgery pathological results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start25 Aug 2017
- Primary completion19 Jun 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao OUYANG, Peking University
- Investigators
- Li-ze Wang, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247478
- Sponsor's protocol ID
- BCP20
- Acronym
- CTREP
- Status last verified
- Sep 2019
- First submitted
- 9 Aug 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure: a Prospective Observational Study Evaluating Response in Axillary Lymph Nodes of Breast Cancer After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03247478
- Acronym / sponsor ID
- CTREP / BCP20
- Conditions
- Invasive Breast Cancer
- Keywords
- Computed tomography (CT) reconstruction, axillary lymph node status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 11 Aug 2017 (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 prospective, single-center, non-randomized, non-controlled observational study.
Detailed description
The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to axillary lymph node. The aim of this study is to determine performance of computed tomography (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| invasive breast cancer | – | –Patients with invasive breast cancer who underwent computed tomography (CT) reconstruction of axillary lymph node for assessment of lymph node response after NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Invasive breast cancer with axillary lymph node metastasis: stage N1-2.
Key inclusion criteria (3 listed)
- Invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB).
- Underwent computed tomography (CT) reconstruction for assessment of axillary lymph node status before and after neoadjuvant chemotherapy (NAC).
- Attend the study voluntarily, sign the informed consent.
Key exclusion criteria (2 listed)
- Contradiction for adjuvant chemotherapy.
- Contradiction for proceeding surgery.
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
Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy.
Time frame: within 6 weeks after obtaining the post-surgery pathological results
Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy will be assessed.
1 secondary outcome
Rreceiver operating characteristic (ROC) curve analysis
Time frame: within 6 weeks after obtaining the post-surgery pathological results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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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. This study is not recruiting at the moment.
Li-ze Wang, MD principal investigator
Peking University Cancer Hospital & Institute
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 Invasive Breast Cancer, run by Peking University 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy. (time frame: within 6 weeks after obtaining the post-surgery pathological results). 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 6 Sep 2019.