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Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT03881384
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
In nonmetastatic local advanced breast cancer patients, we are going to investigate whether circulating tumor DNA (ctDNA) detection can reflect the tumor response to neoadjuvant chemotherapy (NCT) and detect minimal residual disease after surgery.

Condition or disease Intervention/treatment
Breast Neoplasms Other: ctDNA level during neoadjuant chemotherapy

Detailed Description:
Breast cancer is the most common malignant tumor in women worldwide, and chemotherapy is still the main method of breast cancer treatment. And for locally advanced breast cancer patients, neoadjuvant chemotherapy can further improve treatment efficacy, improve prognosis and increase the rate of breast conserving surgery. The persistence of a minimal residual disease at distant sites after the treatment of a localized breast cancer is a key parameter for posttreatment survival but cannot be reliably assessed by the current biological or radiological tools. Therefore, the prediction of the chemotherapy efficacy is very important. ctDNA, corresponds to fragmented DNA released into the blood stream by tumor masses, the detection and quantification of circulating tumor DNA (ctDNA) is a very promising tool that can assess tumor burden, response to therapy, and minimal residual disease. In this study, we wil collect breast cancer cases treated with neoadjuvant chemotherapy, draw blood and evaluate the efficacy each time before chemotherapy and after surgery, then measure the concentration of ctDNA in each sample. We will also analyze the demographic data,basic treatment and follow-up data including relapse, metastasis and survival.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Evaluation of Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients During Neoadjuvant Chemotherapy
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
ctDNA level
ctDNA level during neoadjuant chemotherapy
Other: ctDNA level during neoadjuant chemotherapy
Draw blood from each enrolled patient every time before chemotherapy and measure the ctDNA level in plasma.




Primary Outcome Measures :
  1. The concentration of circulating DNA(ctDNA) [ Time Frame: From date of neoadjuvant chemotherapy decided until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Take the blood each time before chemtherapy and measure the concentration of ctDNA


Biospecimen Retention:   Samples With DNA
tumor biopsy specimen


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that are considered possible candidates for neoadjuvant chemotherapy, by clinical-pathologic features.
Criteria

Inclusion Criteria:

  • Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer;
  • Tumor size ≥ 0.5cm (clinical or radiographic measurements);
  • Any nodal status allowed;
  • Age > 18 years old;
  • Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician;
  • ECOG score<=2;

Exclusion Criteria:

  • Known metastatic disease;
  • With serious heart, lung, liver diseases;
  • Poor cardiac function;
  • Pregnant;
  • Patients with other malignant tumor or treated before;

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): NCT03881384


Contacts
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Contact: Jianjun He, PhD 0086-13992808259 chinahjj@163.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xian Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China, 710061
Contact: Jianjun He, PhD    0086-13992808259    chinahjj@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Jianjun He, PhD First Affiliated Hospital of Xian Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03881384     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2018-001
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
ctDNA

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