NCT03260192

Brief Summary

Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to evaluate patients' response to neoadjuvant chemotherapy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

12.3 years

First QC Date

August 14, 2017

Last Update Submit

January 8, 2024

Conditions

Breast Cancer

Keywords

circulating tumor DNA

Outcome Measures

Primary Outcomes (1)

  • death of breast cancer

    The event is defined as death of breast cancer, which is a separate measure

    Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first.

Secondary Outcomes (1)

  • tumor recurrence or distant metastasis

    Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patient receiving NAC

You may qualify if:

  • Female patients undergoing NAC
  • Age: 18-70 yrs
  • Any menopausal status
  • Any hormal receptor status

You may not qualify if:

  • Metastasis discovered during NAC
  • Lost more than 2 blood samples during NAC and surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunyat-sen Memorial Hospital

Guandong, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. plasma separated within 2 hours in EDTA tubes, stored in -80 celsius refrigerator; 2. plasma in Streck tube, shipped within 3 days to the lab.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • qiang Liu

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunying Li

CONTACT

+86-15915939702lishunying@foxmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 24, 2017

Study Start

September 1, 2013

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

CN(1)