Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

NCT03247478 | Completed

• 1 other identifier: BCP20
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, non-randomized, non-controlled observational study.

Conditions

Invasive Breast Cancer

Keywords

Computed tomography (CT) reconstruction; axillary lymph node status

Outcome Measures

Primary Outcomes (1)

• 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.

  within 6 weeks after obtaining the post-surgery pathological results

Secondary Outcomes (1)

• Rreceiver operating characteristic (ROC) curve analysis

  within 6 weeks after obtaining the post-surgery pathological results

Study Arms (1)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Invasive breast cancer with axillary lymph node metastasis: stage N1-2.

You may qualify if:

• 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.

You may not qualify if:

• Contradiction for adjuvant chemotherapy.
• Contradiction for proceeding surgery.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Axillary lymph node status are determined in FNA/CNB and surgical specimen.

Study Officials

• Li-ze Wang, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Breast Center of Peking University Cancer Hospital

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 11, 2017
• Study Start: August 25, 2017
• Primary Completion: June 19, 2019
• Study Completion: August 30, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

CN (1)