Status:

RECRUITING

ctDNA Monitoring in Early Breast Cancer

Lead Sponsor:

Geneplus-Beijing Co. Ltd.

Collaborating Sponsors:

Army Medical University, China

Conditions:

Breast Cancer

Eligibility:

All Genders

18-80 years

Brief 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 c...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 29 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04353557

Start Date

November 29 2019

End Date

December 1 2026

Last Update

July 18 2024

Active Locations (1)

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Army Medical Center of PLA, China

Chongqing, Chongqing Municipality, China, 400042

ctDNA Monitoring in Early Breast Cancer | DecenTrialz