Clinical Application of ctDNA in Early Screening of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Clinical Application of ctDNA in Early Screening of Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03973034
• Other study ID #: PUMCH-BREAST-ctDNA screening
• Status: Not yet recruiting
• Start date: June 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2019
• Source: Peking Union Medical College Hospital
• Contact: Yidong Zhou, Doctor
• Phone: 86-10-69155200
• Email: zhouyd[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2020
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA test model for early screening of breast cancer		2 years