Health TrialsbyHealthPanel

Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer

ConditionBreast Cancer Screening
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-75
SponsorGeneplus-Beijing Co. Ltd.

About this trial

The purpose of this study is to construct an auxiliary diagnostic model for breast cancer by methylation markers. The study will collect blood and tissue samples from participants with breast cancer and benign disease for whole-genome methylation sequencing. It will screen methylation markers and develop a methylation auxiliary diagnosis model to distinguish between breast cancer and non-cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

With confirmed pathological diagnosis and molecular subtyping results

Ability to provide a written informed consent

Disqualifiers

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

Trial population

Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of breast cancer and benign diseases.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Cancer Arm
Group B: Benign Diseases Arm

Trial outcomes

Primary outcomes

1

Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules.

Time frame
12 months
2

Based on DNA methylation profiles, systematically evaluate the signal, noise, and complementarity of methylation biomarkers and ultimately form a set of diagnostic biomarker combinations for breast malignant nodules.

Time frame
12 months
3

Further develop a methylation assisted diagnostic model that can effectively distinguish between benign and malignant breast nodules.

Time frame
12 months

Secondary outcomes

1

Evaluate the contribution and performance of methylation assisted diagnostic models by integrating imaging and methylation assisted diagnostic model results, and clarify the specificity and sensitivity of integrated model diagnosis.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Geneplus-Beijing Co. Ltd.

Lead sponsor

Chinese Academy of Medical Sciences

Collaborator

Source ClinicalTrials.gov
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