Clinical Application of ctDNA in Early Screening of Breast Cancer

June 2, 2019 updated by: Peking Union Medical College Hospital
The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening of breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Three groups: normal people, benign breast disease patients and breast cancer patients in early stage.

Description

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.
  • Normal people who works as the volunteers.
  • Benign breast disease patients should be diagnosed with confirmed pathology after surgery.
  • Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage.
  • Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.

Exclusion Criteria:

  • Known hypersensitivity reaction to the investigational compounds or incorporated substances.
  • Local recurrence and/or metastasis of breast cancer.
  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal people
Diagnostic test: Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.
Benign breast disease patients
Diagnostic test: Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.
Breast cancer patients in early stage
Diagnostic test: Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ctDNA test model for early screening of breast cancer
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 2, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 2, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-BREAST-ctDNA screening

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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