Clinical Application of ctDNA in Early Screening of Breast Cancer

NCT ID: NCT03973034

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-06-01

Brief Summary

The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening of breast cancer.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal people

Low depth whole genome sequencing

Intervention Type: DIAGNOSTIC_TEST

Low depth whole genome sequencing of the peripheral blood samples from different groups.

Benign breast disease patients

Low depth whole genome sequencing

Intervention Type: DIAGNOSTIC_TEST

Low depth whole genome sequencing of the peripheral blood samples from different groups.

Breast cancer patients in early stage

Low depth whole genome sequencing

Intervention Type: DIAGNOSTIC_TEST

Low depth whole genome sequencing of the peripheral blood samples from different groups.

Interventions

Low depth whole genome sequencing

Low depth whole genome sequencing of the peripheral blood samples from different groups.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
• Age of at least 18 and at most 70 years.
• Normal people who works as the volunteers.
• Benign breast disease patients should be diagnosed with confirmed pathology after surgery.
• Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage.
• Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.

Exclusion Criteria

• Known hypersensitivity reaction to the investigational compounds or incorporated substances.
• Local recurrence and/or metastasis of breast cancer.
• Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
• Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix).
• Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
• Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
• Males.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yidong Zhou, Doctor

Role: CONTACT

zhouyd@pumch.cn

86-10-69155200

Ru Yao, Doctor

Role: CONTACT

yaoru@pumch.cn

86-10-69152001

Other Identifiers

PUMCH-BREAST-ctDNA screening

Identifier Type: -

Identifier Source: org_study_id