Breast CancerNCT03973034
Clinical Application of ctDNA in Early Screening of Breast Cancer
An observational study of Breast Cancer, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Low depth whole genome sequencing
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
Study population: Three groups: normal people, benign breast disease patients and breast cancer patients in early stage.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Low depth whole genome sequencing
- Keywords
- ctDNA, early screening, Copy Number Variants (CNV), Low Depth Whole Genome Sequencing (LDWGS)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low depth whole genome sequencingDiagnostic test
Low depth whole genome sequencing of the peripheral blood samples from different groups.
| Study group | Role | What they receive |
|---|---|---|
| Normal people | Not described Receives: Diagnostic Test: Low depth whole genome sequencing | |
| Benign breast disease patients | Not described Receives: Diagnostic Test: Low depth whole genome sequencing | |
| Breast cancer patients in early stage | Not described Receives: Diagnostic Test: Low depth whole genome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA test model for early screening of breast cancer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973034
- Sponsor's protocol ID
- PUMCH-BREAST-ctDNA screening
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of ctDNA in Early Screening of Breast Cancer
- ClinicalTrials.gov ID
- NCT03973034
- Acronym / sponsor ID
- PUMCH-BREAST-ctDNA screening
- Conditions
- Breast Cancer
- Keywords
- ctDNA, early screening, Copy Number Variants (CNV), Low Depth Whole Genome Sequencing (LDWGS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal people | – | Diagnostic Test: Low depth whole genome sequencing |
| Benign breast disease patients | – | Diagnostic Test: Low depth whole genome sequencing |
| Breast cancer patients in early stage | – | Diagnostic Test: Low depth whole genome sequencing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Three groups: normal people, benign breast disease patients and breast cancer patients in early stage.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low depth whole genome sequencingLow depth whole genome sequencing of the peripheral blood samples from different groups. | Diagnostic test | Benign breast disease patients, Breast cancer patients in early stage, Normal people |
Primary outcome
ctDNA test model for early screening of breast cancer
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yidong Zhou, Doctor (86-10-69155200, zhouyd@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA test model for early screening of breast cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.