Condition or disease | Intervention/treatment |
---|---|
Breast Cancer | Diagnostic Test: Low depth whole genome sequencing |
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Clinical Application of ctDNA in Early Screening of Breast Cancer |
Estimated Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | June 1, 2020 |
Estimated Study Completion Date : | June 1, 2021 |
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.
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yidong Zhou, Doctor | 86-10-69155200 | zhouyd@pumch.cn | |
Contact: Ru Yao, Doctor | 86-10-69152001 | yaoru@pumch.cn |
Tracking Information | |||||
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First Submitted Date | June 2, 2019 | ||||
First Posted Date | June 4, 2019 | ||||
Last Update Posted Date | June 4, 2019 | ||||
Estimated Study Start Date | June 1, 2019 | ||||
Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
ctDNA test model for early screening of breast cancer [ Time Frame: 2 years ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Clinical Application of ctDNA in Early Screening of Breast Cancer | ||||
Official Title | Clinical Application of ctDNA in Early Screening of Breast Cancer | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Three groups: normal people, benign breast disease patients and breast cancer patients in early stage. | ||||
Condition | Breast Cancer | ||||
Intervention | Diagnostic Test: Low depth whole genome sequencing
Low depth whole genome sequencing of the peripheral blood samples from different groups.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
300 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | June 1, 2021 | ||||
Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03973034 | ||||
Other Study ID Numbers | PUMCH-BREAST-ctDNA screening | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Peking Union Medical College Hospital | ||||
Study Sponsor | Peking Union Medical College Hospital | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Peking Union Medical College Hospital | ||||
Verification Date | June 2019 |