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Multimodal Liquid-Biopsy Omics Biomarkers of Treatment Response in Breast Cancer

2026年11月9日 更新者：Chen Kai、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Exploration of Treatment-Response Biomarkers in Breast Cancer Based on Integrated Liquid-Biopsy Multimodal Omics Features

This single-center cohort study integrates humoral immune response profiling (Phage ImmunoPrecipitation Sequencing, PhIP-seq) with circulating cell-free DNA (cfDNA) genomic and epigenomic features, exosome transcriptomics, and plasma metabolomics to discover and validate liquid-biopsy biomarkers of treatment response in breast cancer.

The study comprises four cohorts: (1) a retrospective pan-cancer cohort of approximately 1,000 patients with solid malignant tumor, using archived residual serum/plasma to construct a pan-cancer antigen repertoire and cfDNA mutational/methylation atlas, with priority given to patients who had available Whole Exome Sequencing (WES) data; (2) a prospective cohort of 800 women with non-metastatic (M0) breast cancer receiving standard neoadjuvant chemotherapy (NAC); (3) a prospective cohort of 100 women with metastatic (M1) breast cancer receiving standard systemic therapy; and (4) a control group of 100 individuals, including patients with benign breast disease (breast fibroadenoma) and healthy volunteers.

The primary objective is to identify biomarkers-autoantibody repertoires, cfDNA mutation clearance, methylation reprogramming, exosome transcripts, and metabolic signatures-associated with pathological complete response (pCR) to NAC, and to develop predictive models where feasible.

研究概览

地位

招聘中

条件

详细说明

Peripheral blood (20 mL) is collected at protocol-defined time points. Serum/Plasma autoantibody repertoires are profiled by PhIP-seq(phage-display immunoprecipitation sequencing); cfDNA methylation is measured by bisulfite-free methylome profiling; exosome RNA is profiled by strand-specific RNA sequencing; and untargeted plasma metabolomics is performed by liquid chromatography-tandem mass spectrometry. The study endpoints include clinical response and pathological complete response after NAC, together with survival follow-up. The study is conducted in accordance with the Declaration of Helsinki and Chinese regulations for investigator-initiated research, and has been approved by the institutional ethics committee.

Ambispective - a retrospective pan-cancer cohort (archived samples, 2020 Jan - 2026. Sep) combined with prospective breast cancer cohorts (enrollment 2026. Oct -2029)

研究类型

观察性的

注册 (估计的)

2000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Guangdong
      • Shanwei、Guangdong、中国、516601
        • 招聘中
        • Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Study participants will be selected from three main sources: (1) healthy female volunteers recruited for this study; (2) patients receiving clinical treatment at our institution; and (3) patients undergoing relevant diagnostic or clinical examinations at our institution.

描述

Inclusion Criteria:

Retrospective pan-cancer cohort:

  1. Aged 18 to 80 years;
  2. Both genders
  3. Clinically and histopathologically confirmed diagnosis of solid malignant tumors, including but not limited to non-small cell lung cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma, or breast cancer.
  4. Complete clinical data available, including definitive TNM stage and established treatment plan;
  5. Archived peripheral blood samples (serum/plasma) collected during routine clinical care.

Prospective neoadjuvant chemotherapy (NAC) breast cancer cohort:

  1. Female, aged 18 to 80 years (inclusive);
  2. Clinically and pathologically confirmed non-metastatic (M0) breast cancer;
  3. Planned standard NAC at the study site, with complete pre-treatment ER, PR, and HER2 immunohistochemistry results available;
  4. Voluntary participation with signed written informed consent.

Prospective metastatic breast cancer cohort:

  1. Female, aged 18 to 80 years (inclusive);
  2. Clinically and pathologically confirmed metastatic (M1) breast cancer;
  3. Planned standard systemic therapy at the study site, with complete ER, PR, and HER2 immunohistochemistry results available;
  4. Voluntary participation with signed written informed consent.

Benign/Healthy control group:

  1. Healthy female volunteers, or female patients with breast fibroadenoma undergoing minimally invasive biopsy during the same period;
  2. Voluntary participation with signed written informed consent.

Exclusion Criteria:

For prospective breast cancer cohorts:

  1. History of mastitis, or systemic rheumatic/autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis);
  2. Acute or chronic infectious diseases within the past 6 months (e.g., pneumonia, pulmonary tuberculosis, active hepatitis);
  3. Long-term use of glucocorticoids, immunosuppressants, biologic agents, or psychotropic medications (short-term or as-needed use excepted);
  4. Inability or refusal to provide informed consent.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：OTHER

队列和干预

团体/队列
Retrospective Pan-Cancer Cohort

Patients aged 18-80 years with histologically confirmed solid malignant tumors( e.g. non-small cell lung cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma, or breast cancer), diagnosed at the study site between January 2020 and Sep 2026, with complete clinical data (TNM stage and treatment plan) and archived residual serum/plasma samples. Approximately 1,000 cases.
Prospective Neoadjuvant Chemotherapy (NAC) Breast Cancer Cohort

Women aged 18-80 years with clinically and pathologically confirmed non-metastatic (M0) breast cancer who plan to receive standard NAC at the study site, with complete pre-treatment ER, PR, and HER2 immunohistochemistry results. Planned enrollment: 800. Peripheral blood (20 mL) is collected before, during, and after NAC (pre-surgery), in addition to routine clinical data.
Prospective Benign/Control Group (Breast Fibroadenoma or Healthy Volunteers)

Patients with breast fibroadenoma undergoing minimally invasive biopsy during the same period, serving as benign controls to calibrate background signals of circulating antigens and liquid-biopsy analytes. Healthy female volunteers will also be enrolled. Planned enrollment: 100.
Prospective Metastatic Breast Cancer Cohort

Women aged 18-80 years with clinically and pathologically confirmed metastatic (M1) breast cancer who plan to receive standard systemic therapy at the study site, with complete ER, PR, and HER2 immunohistochemistry results.Planned enrollment: 100. Serial peripheral blood samples are collected before, during, and after treatment.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pathological Complete Response (pCR) Rate
大体时间：At definitive surgery after completion of NAC (approximately 4-6 months after NAC initiation)

Proportion of patients achieving pCR after completion of neoadjuvant chemotherapy, defined as ypT0/is ypN0 (no invasive cancer in the breast and ipsilateral axillary lymph nodes; ductal carcinoma in situ may be present), consistent with RCB-0.
At definitive surgery after completion of NAC (approximately 4-6 months after NAC initiation)

次要结果测量

结果测量
措施说明
大体时间
Residual Cancer Burden (RCB) Class
大体时间：At definitive surgery after completion of NAC (approximately 4-6 months after NAC initiation)

RCB class (RCB-0, RCB-I, RCB-II, RCB-III) quantifying residual tumor in the breast and lymph nodes after neoadjuvant therapy, calculated using the internationally validated MD Anderson Cancer Center RCB calculator based on standardized pathological assessment of surgical specimens.
At definitive surgery after completion of NAC (approximately 4-6 months after NAC initiation)
Invasive Disease-Free Survival (iDFS)
大体时间：From enrollment until event or study end, assessed every 6 months (up to approximately 5 years)

Time from enrollment to the first occurrence of any of the following: ipsilateral invasive breast cancer recurrence, contralateral invasive breast cancer, distant metastasis, second primary non-breast invasive malignancy, or death from any cause (conservative definition including all deaths), per established consensus definitions. Follow-up includes clinical visits and imaging (breast ultrasound/MRI, chest-abdominal CT, bone scan as risk-stratified) every 6 months.
From enrollment until event or study end, assessed every 6 months (up to approximately 5 years)
Progression-Free Survival (PFS)
大体时间：From enrollment until event or study end (up to approximately 5 years)

Time from enrollment to the first radiographically confirmed disease progression (per RECIST 1.1) or death from any cause. This outcome is only available for M1 patients.
From enrollment until event or study end (up to approximately 5 years)
Overall Survival (OS)
大体时间：From enrollment until death or study end (up to approximately 5 years or longer)

Time from enrollment to death from any cause. Death events are confirmed by death certificates, hospital records, or national vital registration systems. Patients lost to follow-up are censored at the date of last contact.
From enrollment until death or study end (up to approximately 5 years or longer)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

合作者

Shenshan Medical Center of Sun Yat-sen Memorial Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月12日

初级完成 (估计的)

2030年6月30日

研究完成 (估计的)

2034年12月30日

研究注册日期

首次提交

2026年10月11日

首先提交符合 QC 标准的

2026年10月11日

首次发布 (实际的)

2026年10月19日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-SSKY-048
  • 2026-SSKY-048 (其他标识符：Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

De-identified individual participant data may be made available upon reasonable request to the corresponding investigator after publication of the primary results, subject to institutional and ethics committee approval.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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