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Clinical Application of CTDNA in Operable Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT02797652
Recruitment Status : Unknown
Verified June 2016 by Qiang SUN, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Qiang SUN, Peking Union Medical College Hospital

Brief Summary:
Our study aims to evaluate the possibility of clinical application of CTDNA 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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Neoadjuvant chemotherapy before surgery Procedure: Surgery followed by adjuvant chemotherapy

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Application of CTDNA in Operable Breast Cancer Patients
Study Start Date : May 2016
Estimated Primary Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Neoadjuvant chemotherapy
ctDNA 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
The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.

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




Primary Outcome Measures :
  1. The number of ctDNA copies per milliliter in patients' peripheral blood [ Time Frame: 2 years ]
    The number of ctDNA copies per milliliter in patients' peripheral blood of neoadjuvant chemotherapy group and surgery group in different periods



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Operable breast cancer patients who need chemotherapy before or after surgery.
Criteria

Inclusion Criteria:

  1. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
  2. Age of at least 18 and at most 70 years.
  3. Performance status (Karnofsky-Index) >80%.
  4. Chemotherapy is necessary before or after surgery.
  5. No clinical evidence of local recurrence or distant metastases.
  6. 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.
  7. Life expectancy of at least 2 years, disregarding the diagnosis of cancer.
  8. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
  9. Patients must be available for and compliant to treatment and follow-up.
  10. Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

  1. Known hypersensitivity reaction to the investigational compounds or incorporated substances.
  2. Local recurrence and/or metastasis of breast cancer.
  3. No need of chemotherapy.
  4. 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)

  5. Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias
  6. Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
  7. Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
  8. Males.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797652


Contacts
Contact: Qiang Sun, Doctor 86-010-69152701 sunqiangpumc@sina.com
Contact: Li Peng, Doctor 86-010-69152701 pl226@sina.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Qiang Sun, Doctor    86-010-69152701    sunqiangpumc@163.com   
Contact: Li Peng, Doctor    86-010-69152701    pl226@sina.com   
Principal Investigator: Yidong Zhou, Doctor         
Sub-Investigator: Li Peng, Doctor         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Qiang Sun, Doctor Peking Union Medical College Hospital

Publications:

Responsible Party: Qiang SUN, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02797652     History of Changes
Other Study ID Numbers: PUMCH-BREAST-CTDNA
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Qiang SUN, Peking Union Medical College Hospital:
Breast cancer
ctDNA
Neoadjuvant chemotherapy
Adjuvant chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases