Clinical Application of CTC in Operable Breast Cancer Patients

NCT ID: NCT03842176

Last Updated: 2019-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Neoadjuvant chemotherapy before surgery

Intervention Type PROCEDURE

The operable breast cancer patients takes 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.

Surgery followed by adjuvant chemotherapy

Intervention Type PROCEDURE

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

Interventions

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Neoadjuvant chemotherapy before surgery

The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.

Intervention Type PROCEDURE

Surgery followed by adjuvant chemotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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ZHOU Yidong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yidong Zhou, Doctor

Role: CONTACT

86-010-69155200

Ru Yao, Doctor

Role: CONTACT

86-10-69152001

Facility Contacts

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Yidong Zhou, Doctor

Role: primary

86-010-69155200

Other Identifiers

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PUMCH-BREAST-CTC

Identifier Type: -

Identifier Source: org_study_id

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