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NCT Number: NCT04353557

ctDNA Monitoring in Early Breast Cancer

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.

Recruiting

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Army Medical Center of PLA, China

Chongqing, Chongqing Municipality, 400042, China

Location status: Recruiting

Location contact

Yan Xu, M.D.

CONTACT

[email protected]

(+86)159 2310 0038

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Positive ctDNA detection at first post-operative timepoint

    Time frame: 1 month post-surgery

    The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint

Secondary outcomes

  1. Positive ctDNA detection at post-operative timepoints

    Time frame: 6/12/18/24/30 months

    The proportion of patients with ctDNA positivity as assessed by the blood sample taken at other post-operative timepoints

  2. Association between ctDNA detection and time to recurrence

    Time frame: 1 month post-surgery

    Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA comparison.

  3. Association between ctDNA detection and time to recurrence

    Time frame: 6/12/18/24/30 months

    Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Xu, M.D.

CONTACT

[email protected]

(+86)159 2310 0038

Sponsors and collaborators

Lead sponsor

Geneplus-Beijing Co. Ltd.

Industry

Collaborators

  • Army Medical University, China

Registry information

Official study title

Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2020
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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