Using blood tests to help diagnose breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop an auxiliary diagnostic model for breast cancer by analyzing methylation markers in blood and tissue samples. Participants with confirmed breast cancer and benign conditions will provide samples for whole-genome methylation sequencing. The goal is to identify specific methylation markers that can effectively differentiate between breast cancer and non-cancerous conditions. This observational study will enhance diagnostic accuracy and potentially improve early detection of breast cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria for All the Participants:

* With confirmed pathological diagnosis and molecular subtyping results
* Ability to provide a written informed consent

Exclusion Criteria for Cancer Arm Participants:

* Patients with a history of or currently suffering from other malignancies
* Pregnant or planning to become pregnant female patients
* Patients who have received cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy, before blood draw
* Patients with a history of blood transfusion within the past month
* Patients with a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* Patients with persistent fever or undergoing anti-inflammatory treatment within 14 days before blood draw
* Any other conditions that the researcher deems may make the patient unsuitable for inclusion in the study or may interfere with the completion of the study
* Patients in poor physical condition who are not suitable for blood draw
* Patients who cannot provide informed consent or refuse blood draw

Exclusion Criteria for Benign Diseases Arm Participants:

* History of malignancies
* Current malignancies or precancerous lesions

Where it's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How breast density affects mammogram screening and follow-up

  This project will test whether women aged 45–75 with dense breasts have more recalls and additional diagnostic tests after routine mammograms than women with less dense breasts.

  Recruiting Azienda Sanitaria Locale CN2 Alba-Bra · Verduno, Italy/CN · NCT07415499

• AI-enhanced breast imaging for population screening

  This project will test whether combining AI-assisted breast ultrasound and AI-assisted mammography improves detection accuracy and efficiency for women aged 35–69 in population-based breast cancer screening.

  Recruiting Fudan University · Shanghai, Shaghai · NCT07411443

• Bundled breast and colorectal screening plus genetic navigation

  This program will test whether offering combined navigation for both breast and colorectal cancer screening, with genetic services when needed, helps Black and Hispanic women aged 45–74 complete recommended tests better than breast-only navigation.

  Recruiting at 2 sites Georgetown University · Newark, Delaware and 1 other locations · NCT07228000

• Single radiologist with AI support versus two radiologists for screening mammograms

  This trial will see if one radiologist aided by AI can match the performance of the usual two-radiologist reading for screening mammograms in women aged 45–69.

  Recruiting University Hospital Olomouc · Olomouc · NCT07075679

• Comparing the MAMMOMAT B.brilliant and Revelation mammography systems

  We will try two FDA‑approved mammogram machines to see which shows suspicious breast calcifications more clearly in women having diagnostic mammography.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT07067788

• Screening mammograms with or without AI assistance for breast cancer detection

  This trial will try using an FDA-cleared AI tool to help radiologists read screening mammograms for adults to see if it finds more cancers and reduces unnecessary callbacks.

  Recruiting at 6 sites Phase 4 Jonsson Comprehensive Cancer Center · Los Angeles, California and 5 other locations · NCT06934239

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.