Clinical Application of ctDNA in Early Screening of Breast Cancer

NCT03973034 | Unknown

• 1 other identifier: PUMCH-BREAST-ctDNA screening
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Keywords

ctDNA; early screening; Copy Number Variants (CNV); Low Depth Whole Genome Sequencing (LDWGS)

Outcome Measures

Primary Outcomes (1)

• ctDNA test model for early screening of breast cancer

  2 years

Study Arms (3)

Normal people

Diagnostic Test: Low depth whole genome sequencing

Benign breast disease patients

Diagnostic Test: Low depth whole genome sequencing

Breast cancer patients in early stage

Diagnostic Test: Low depth whole genome sequencing

Interventions

Low depth whole genome sequencing DIAGNOSTIC_TEST

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

Benign breast disease patients; Breast cancer patients in early stage; Normal people

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three groups: normal people, benign breast disease patients and breast cancer patients in early stage.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yidong Zhou, Doctor

CONTACT

86-10-69155200; zhouyd@pumch.cn

Ru Yao, Doctor

CONTACT

86-10-69152001; yaoru@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 4, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: June 4, 2019

Record last verified: 2019-06