NCT03842176

Brief Summary

The investigators aim to evaluate the possibility of clinical application of CTC detection in samples or peripheral blood of breast cancer patients, so as to act as the new techniques or indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast cancer.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration 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

July 1, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

February 13, 2019

Last Update Submit

April 1, 2019

Conditions

Breast Cancer

Keywords

Breast CancerCTCNeoadjuvant chemotherapyAdjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • The level of CTC mRNA markers in patients' peripheral blood

    The level of CTC mRNA markers in patients' peripheral blood of neoadjuvant chemotherapy group and surgery group in different periods

    3 years

Study Arms (2)

Neoadjuvant chemotherapy

CTC of operable breast cancer patients with neoadjuvant chemotherapy before surgery in different periods: before neo-chemotherapy, during neo-chemotherapy, on surgery day, after surgery and follow-up time.

Procedure: Neoadjuvant chemotherapy before surgery

Surgery

CTC of operable breast cancer patients with surgery followed by adjuvant chemotherapy in different periods: on surgery day, after surgery, before adjuvant chemotherapy, during adjuvant chemotherapy, and follow-up time.

Procedure: Surgery followed by adjuvant chemotherapy

Interventions

Neoadjuvant chemotherapy before surgeryPROCEDURE

The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.

Neoadjuvant chemotherapy
Surgery followed by adjuvant chemotherapyPROCEDURE

The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.

Surgery

Eligibility Criteria

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

Operable breast cancer patients who need chemotherapy before or after surgery.

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.
  • Performance status (Karnofsky-Index) \>80%.
  • Chemotherapy is necessary before or after surgery.
  • No clinical evidence of local recurrence or distant metastases.
  • Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
  • Life expectancy of at least 2 years, disregarding the diagnosis of cancer.
  • Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
  • Patients must be available for and compliant to treatment and follow-up.
  • Patients registered on this trial must be treated and followed up at the participating center.

You may not qualify if:

  • Known hypersensitivity reaction to the investigational compounds or incorporated substances.
  • Local recurrence and/or metastasis of breast cancer.
  • No need of chemotherapy.
  • 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).
  • Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yidong Zhou, Doctor

CONTACT

86-010-69155200zhouyd@pumch.cn

Ru Yao, Doctor

CONTACT

86-10-69152001yaoru@pumch.cn

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

February 13, 2019

First Posted

February 15, 2019

Study Start

July 1, 2016

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

April 3, 2019

Record last verified: 2019-04

Locations

CN(1)