Breast CarcinomaNCT04671498
Droplet-BC Screening Test for the Detection of Breast Cancer, the DROPLET-BC Study
An observational study of Breast Carcinoma, run by Preferred Medicine, Inc at 3 sites in United States.
Trial summary
This study investigates if a new type of test called Droplet-BC screening test can classify breast cancer patients from non-cancer volunteers by circulating small-noncoding RNA in the blood with a statistical validity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Biospecimen Collection, Droplet-BC Test and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Nov 2020to 31 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients and non-cancer volunteers.
Who may be able to join
- BREAST CANCER PATIENTS: Newly diagnosed with breast cancer
- BREAST CANCER PATIENTS: Not received cancer treatment for newly diagnosed with breast cancer
- BREAST CANCER PATIENTS: Able to comprehend, sign, and date the written informed consent document to participate in the study
- BREAST CANCER PATIENTS: Able and willing to provide a one-time blood sample
- BREAST CANCER PATIENTS: Age >= 18 years old
- NON-CANCER VOLUNTEERS: Have undergone a screening mammogram
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- NON-CANCER VOLUNTEERS: Not currently taking any drugs for cancer treatment or any cancer prevention medication
- NON-CANCER VOLUNTEERS: Able to comprehend, sign, and date the written informed consent document to participate in this study
- NON-CANCER VOLUNTEERS: Able and willing to provide blood samples according to provided written instructions
- NON-CANCER VOLUNTEERS: Seen by a provider (physician or advanced practice nurse [APN]) in the Cancer Prevention clinic at MD Anderson Cancer Center or other participating sites
- NON-CANCER VOLUNTEERS: Age >= 18 years old
Who cannot join
- BREAST CANCER PATIENTS: Known current pregnancy
- BREAST CANCER PATIENTS: History of breast cancer treatment in the past
- BREAST CANCER PATIENTS: Participation in any interventional clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
- BREAST CANCER PATIENTS: Any condition that, in the opinion of the investigator, should preclude participation in the study
- NON-CANCER VOLUNTEERS: Known current pregnancy
- NON-CANCER VOLUNTEERS: History of breast cancer (breast ductal carcinoma in situ [DCIS] and invasive)
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- NON-CANCER VOLUNTEERS: History of any cancer except non-melanoma skin cancer and cervical dysplasia
- NON-CANCER VOLUNTEERS: Participation in any interventional clinical study within the previous 30 days in which experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
- NON-CANCER VOLUNTEERS: Any condition that in the opinion of the investigator, should preclude participation in the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Shipra Gandhi, MD, 716-845-1285
Shipra Gandhi, MD
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Seema A Khan, MD, 312-695-0990
Seema A Khan, MD
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Naoto T. Ueno, 713-792-2817
Naoto T. Ueno
About this study
Official title: Detection by Circulating RNA With Optimized Machine Learning Technology for Breast Cancer: DROPLET-BC Study
This study investigates if a new type of test called Droplet-BC screening test can classify breast cancer patients from non-cancer volunteers by circulating small-noncoding RNA in the blood with a statistical validity. This study also investigates if this test can classify the subgroup of breast cancer patients with a variety of conditions. Information from this study may provide a new method of breast cancer screening/diagnosis
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the sensitivity and specificity of the Droplet-BC screening test for distinguishing breast cancer (BC) patients from non-cancer volunteers, using reference data confirmed at sites.
SECONDARY OBJECTIVES:
- To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the classification of early-stage BC.
II. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for classifying patients into non-cancer volunteer (Breast Imaging-Reporting and Data System [BI-RADS] Categories 1 and 2) and BC patient subgroups.
III. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test to classify different subgroups between non-cancer volunteers (BI-RADS category 1) versus BC patients plus non-cancer volunteers (BI- RADS category 2).
IV. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study).
- To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the multi-classification among cancer stage.
VI. To compare the sensitivity of the Droplet-BC test with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results.
VII. To compare the sensitivity of the Droplet-BC test with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results.
VIII. To compare the sensitivity of the Droplet-BC test with MRI for detecting BC by extracting a subgroup of BC patients that have magnetic resonance imaging (MRI) results.
IX. To conduct all analyses described above with subgroups of participants matched as closely as possible for age, race/ethnicity, cancer history, current medication, family history of cancer, and/or breast cancer gene (BRCA) status.
EXPLORATORY OBJECTIVES:
- To evaluate the sensitivity and specificity of the Droplet-BC test to detect cancer among different age groups.
II. To evaluate the sensitivity and specificity of the Droplet-BC test to detect cancer among individuals of differing ethnicities.
III. To compare expression levels of small ribonucleic acid (RNAs) among different age groups.
IV. To compare expression levels of small RNAs among individuals of differing ethnicities.
OUTLINE:
Participants undergo collection of blood sample for the Droplet-BC test. Breast cancer patients' medical records are also reviewed.
- Conditions
- Breast Carcinoma
- Being tested
- Biospecimen Collection, Droplet-BC Test, Electronic Health Record Review
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood sample
Droplet-BC TestProcedure or surgery
Undergo Droplet-BC Test
Electronic Health Record ReviewOther
Medical records are reviewed
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-correlative (biospecimen collection) (Breast Cancer patients) | Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. Receives: Procedure: Biospecimen Collection; Procedure: Droplet-BC Test; Other: Electronic Health Record Review | |
| Ancillary-correlative (biospecimen collection) (Volunteer) | Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. Receives: Procedure: Biospecimen Collection; Procedure: Droplet-BC Test; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Droplet-BC screening test for detecting breast cancer
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for detecting breast cancer
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Secondary outcomes (13)
Sensitivity of the Droplet-BC screening test for the classification of early-stage breast cancer (BC)
Early-stage means breast ductal carcinoma in situ (DCIS) stage and stage I/II BC. Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of early-stage breast cancer
Early-stage means DCIS stage and stage I/II BC. Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (Breast Imaging Reporting and Data System [BI-RADS] categories 1 and 2) and BC patient subgroups
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (BI-RADS categories 1 and 2) and BC patient subgroups
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2)
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2)
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study)
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study)
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC test compared with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC test compared with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Sensitivity of Droplet-BC test compared with magnetic resonance imaging (MRI) for detecting BC by extracting a subgroup of BC patients that have MRI results
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Measured: Up to study completion (estimated 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start3 Nov 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Preferred Medicine, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Naoto T Ueno, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671498
- Sponsor's protocol ID
- 2020-0724
- Other IDs
- NCI-2020-08583, 2020-0724, MOD00009113 / IC-1243721
- Status last verified
- Jun 2022
- First submitted
- 4 Dec 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection by Circulating RNA With Optimized Machine Learning Technology for Breast Cancer: DROPLET-BC Study
- ClinicalTrials.gov ID
- NCT04671498
- Acronym / sponsor ID
- 2020-0724
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Preferred Medicine, IncIndustry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Dec 2020 (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.
This study investigates if a new type of test called Droplet-BC screening test can classify breast cancer patients from non-cancer volunteers by circulating small-noncoding RNA in the blood with a statistical validity. This study also investigates if this test can classify the subgroup of breast cancer patients with a variety of conditions. Information from this study may provide a new method of breast cancer screening/diagnosis
Detailed description
PRIMARY OBJECTIVE:
- To determine the sensitivity and specificity of the Droplet-BC screening test for distinguishing breast cancer (BC) patients from non-cancer volunteers, using reference data confirmed at sites.
SECONDARY OBJECTIVES:
- To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the classification of early-stage BC.
II. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for classifying patients into non-cancer volunteer (Breast Imaging-Reporting and Data System [BI-RADS] Categories 1 and 2) and BC patient subgroups.
III. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test to classify different subgroups between non-cancer volunteers (BI-RADS category 1) versus BC patients plus non-cancer volunteers (BI- RADS category 2).
IV. To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study).
- To determine the performance (sensitivity and specificity) of the Droplet-BC screening test for the multi-classification among cancer stage.
VI. To compare the sensitivity of the Droplet-BC test with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results.
VII. To compare the sensitivity of the Droplet-BC test with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results.
VIII. To compare the sensitivity of the Droplet-BC test with MRI for detecting BC by extracting a subgroup of BC patients that have magnetic resonance imaging (MRI) results.
IX. To conduct all analyses described above with subgroups of participants matched as closely as possible for age, race/ethnicity, cancer history, current medication, family history of cancer, and/or breast cancer gene (BRCA) status.
EXPLORATORY OBJECTIVES:
- To evaluate the sensitivity and specificity of the Droplet-BC test to detect cancer among different age groups.
II. To evaluate the sensitivity and specificity of the Droplet-BC test to detect cancer among individuals of differing ethnicities.
III. To compare expression levels of small ribonucleic acid (RNAs) among different age groups.
IV. To compare expression levels of small RNAs among individuals of differing ethnicities.
OUTLINE:
Participants undergo collection of blood sample for the Droplet-BC test. Breast cancer patients' medical records are also reviewed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (biospecimen collection) (Breast Cancer patients) | – | Procedure: Biospecimen Collection, Procedure: Droplet-BC Test, Other: Electronic Health Record ReviewParticipants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. |
| Ancillary-correlative (biospecimen collection) (Volunteer) | – | Procedure: Biospecimen Collection, Procedure: Droplet-BC Test, Other: Electronic Health Record ReviewParticipants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients and non-cancer volunteers.
Key inclusion criteria (11 listed)
- BREAST CANCER PATIENTS: Newly diagnosed with breast cancer
- BREAST CANCER PATIENTS: Not received cancer treatment for newly diagnosed with breast cancer
- BREAST CANCER PATIENTS: Able to comprehend, sign, and date the written informed consent document to participate in the study
- BREAST CANCER PATIENTS: Able and willing to provide a one-time blood sample
- BREAST CANCER PATIENTS: Age >= 18 years old
Key exclusion criteria (9 listed)
- BREAST CANCER PATIENTS: Known current pregnancy
- BREAST CANCER PATIENTS: History of breast cancer treatment in the past
- BREAST CANCER PATIENTS: Participation in any interventional clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
- BREAST CANCER PATIENTS: Any condition that, in the opinion of the investigator, should preclude participation in the study
- NON-CANCER VOLUNTEERS: Known current pregnancy
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood sample | Procedure or surgery | Ancillary-correlative (biospecimen collection) (Breast Cancer patients), Ancillary-correlative (biospecimen collection) (Volunteer) |
| Droplet-BC TestUndergo Droplet-BC Test | Procedure or surgery | Ancillary-correlative (biospecimen collection) (Breast Cancer patients), Ancillary-correlative (biospecimen collection) (Volunteer) |
| Electronic Health Record ReviewMedical records are reviewed | Other | Ancillary-correlative (biospecimen collection) (Breast Cancer patients), Ancillary-correlative (biospecimen collection) (Volunteer) |
Primary outcome
Sensitivity of the Droplet-BC screening test for detecting breast cancer
Time frame: Up to study completion (estimated 18 months)
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
Specificity of the Droplet-BC screening test for detecting breast cancer
Time frame: Up to study completion (estimated 18 months)
Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.
13 secondary outcomes
Sensitivity of the Droplet-BC screening test for the classification of early-stage breast cancer (BC)
Time frame: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of early-stage breast cancer
Time frame: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (Breast Imaging Reporting and Data System [BI-RADS] categories 1 and 2) and BC patient subgroups
Time frame: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (BI-RADS categories 1 and 2) and BC patient subgroups
Time frame: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2)
Time frame: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2)
Time frame: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study)
Time frame: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study)
Time frame: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV
Time frame: Up to study completion (estimated 18 months)
Specificity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV
Time frame: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC test compared with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results
Time frame: Up to study completion (estimated 18 months)
Sensitivity of the Droplet-BC test compared with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results
Time frame: Up to study completion (estimated 18 months)
Sensitivity of Droplet-BC test compared with magnetic resonance imaging (MRI) for detecting BC by extracting a subgroup of BC patients that have MRI results
Time frame: Up to study completion (estimated 18 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Naoto T Ueno principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Preferred Medicine, Inc at 3 sites in United States.
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 11 inclusion and 9 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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Naoto T Ueno (713-792-2817, nueno@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the Droplet-BC screening test for detecting breast cancer (time frame: Up to study completion (estimated 18 months)). The study lists 2 primary outcomes in all. 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 21 Jun 2022.