RecruitingNCT04353557

ctDNA Monitoring in Early Breast Cancer

Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer


Sponsor

Geneplus-Beijing Co. Ltd.

Enrollment

200 participants

Start Date

Nov 29, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • Patients aged 18 to 80 years old
  • Histologically proven primary breast cancer with clinical stage I-III
  • Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).
  • Expected to achieve R0 resection.
  • Estimated lifetime is more than 3 months.
  • Signed Informed Consent Form
  • Consent to provide research blood samples.

Exclusion Criteria4

  • Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5.
  • Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5.
  • Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.
  • Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.

Locations(1)

Army Medical Center of PLA, China

Chongqing, Chongqing Municipality, China

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NCT04353557


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